Adverse Event Report

Report

reporttype2Version of Safety Report ID15receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10265600serious1Date Last Updated08/07/2016seriousnesslifethreatening1receiptdateformat102seriousnessdeath1companynumbADR-2014-01062occurcountryGBseriousnessother1duplicate1Date Received24/06/2014seriousnesshospitalization1transmissiondate09/11/2016primarysourcecountryGB

Primary Source

reportercountryGBqualification1

Patient

Onset Age39Unit of Onset AgeyearsSexMale

Contents

Reaction

1)

reactionmeddraversionpt19.1ReactionAnxietyOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionConjunctival hyperaemiaOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionImpaired healingOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionAlcohol abuseOutcomeFatal

5)

reactionmeddraversionpt19.1ReactionGamma-glutamyltransferase abnormalOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionMuscular weaknessOutcomeRecovered/resolved

7)

reactionmeddraversionpt19.1ReactionFatigueOutcomeRecovered/resolved

8)

reactionmeddraversionpt19.1ReactionErectile dysfunctionOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionMuscle spasticityOutcomeUnknown

10)

reactionmeddraversionpt19.1ReactionMacrophages increasedOutcomeUnknown

11)

reactionmeddraversionpt19.1ReactionAdverse drug reactionOutcomeUnknown

12)

reactionmeddraversionpt19.1ReactionGastritisOutcomeRecovered/resolved

13)

reactionmeddraversionpt19.1ReactionScratchOutcomeUnknown

14)

reactionmeddraversionpt19.1ReactionWound dehiscenceOutcomeRecovered/resolved

15)

reactionmeddraversionpt19.1ReactionMalaiseOutcomeUnknown

16)

reactionmeddraversionpt19.1ReactionPulmonary oedemaOutcomeUnknown

17)

reactionmeddraversionpt19.1ReactionCoughOutcomeRecovered/resolved

18)

reactionmeddraversionpt19.1ReactionOnychomycosisOutcomeUnknown

19)

reactionmeddraversionpt19.1ReactionImplant site infectionOutcomeRecovered/resolved

20)

reactionmeddraversionpt19.1ReactionFallOutcomeUnknown

21)

reactionmeddraversionpt19.1ReactionCardiomegalyOutcomeUnknown

22)

reactionmeddraversionpt19.1ReactionHepatic steatosisOutcomeUnknown

23)

reactionmeddraversionpt19.1ReactionNauseaOutcomeRecovered/resolved

24)

reactionmeddraversionpt19.1ReactionDepressionOutcomeUnknown

25)

reactionmeddraversionpt19.1ReactionPetechiaeOutcomeUnknown

26)

reactionmeddraversionpt19.1ReactionScarOutcomeUnknown

27)

reactionmeddraversionpt19.1ReactionWound infectionOutcomeRecovered/resolved

28)

reactionmeddraversionpt19.1ReactionAlcohol poisoningOutcomeFatal

29)

reactionmeddraversionpt19.1ReactionPain in extremityOutcomeUnknown

30)

reactionmeddraversionpt19.1ReactionDiarrhoeaOutcomeRecovered/resolved

31)

reactionmeddraversionpt19.1ReactionHeadacheOutcomeRecovered/resolved

32)

reactionmeddraversionpt19.1ReactionNeutrophil count increasedOutcomeUnknown

33)

reactionmeddraversionpt19.1ReactionStressOutcomeRecovered/resolved

34)

reactionmeddraversionpt19.1ReactionSudden deathOutcomeFatal

35)

reactionmeddraversionpt19.1ReactionTherapeutic response unexpectedOutcomeUnknown

36)

reactionmeddraversionpt19.1ReactionToxicity to various agentsOutcomeUnknown

37)

reactionmeddraversionpt19.1ReactionHypotoniaOutcomeRecovered/resolved

38)

reactionmeddraversionpt19.1ReactionPulmonary congestionOutcomeUnknown

39)

reactionmeddraversionpt19.1ReactionPurulent dischargeOutcomeRecovered/resolved

40)

reactionmeddraversionpt19.1ReactionMental disorderOutcomeUnknown

41)

reactionmeddraversionpt19.1ReactionImplant site extravasationOutcomeRecovered/resolved

42)

reactionmeddraversionpt19.1ReactionSkin ulcerOutcomeRecovered/resolved

43)

reactionmeddraversionpt19.1ReactionBlood ethanol increasedOutcomeUnknown

44)

reactionmeddraversionpt19.1ReactionCondition aggravatedOutcomeFatal

45)

reactionmeddraversionpt19.1ReactionInjuryOutcomeRecovered/resolved

46)

reactionmeddraversionpt19.1ReactionVomitingOutcomeRecovered/resolved

47)

reactionmeddraversionpt19.1ReactionIntentional self-injuryOutcomeRecovered/resolved

48)

reactionmeddraversionpt19.1ReactionAccidental deathOutcomeFatal

49)

reactionmeddraversionpt19.1ReactionTherapeutic response decreasedOutcomeRecovered/resolved

50)

reactionmeddraversionpt19.1ReactionUpper respiratory tract infectionOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext248.7200012 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate04/02/2014drugenddateformat102drugenddate06/02/2014actiondrug2drugadditional1

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

2)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext207.44 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate07/02/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

3)

drugcharacterization1medicinalproductRAMIPRIL.drugdosagetext2.5 MGdrugadministrationroute048drugstartdateformat102drugstartdate13/01/2014

activesubstance

activesubstancenameRAMIPRIL

openFDA Info on Medication

Application Number ANDA077626, ANDA078832, NDA019901, ANDA090697, ANDA077900, ANDA091604, ANDA20239 ... Brand NameRAMIPRIL, ALTACEGeneric NameRAMIPRILManufacturers Lupin Pharmaceuticals, Inc., Cadila Healthcare Limited, Pfizer Laboratories Div ... product_ndc 68180-589, 68180-588, 68180-590, 68180-591, 65841-655, 65841-656, 65841-657, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMIPRILRXCUI 198188, 198189, 261962, 845488, 104384, 104385, 260333, 845489, 251856, 251857, ... spl_id 4b7f8574-0917-4473-a291-6fe01b23ef30, 5c6923e7-888e-4ea4-a32b-7f0dffe52231, adc2 ... spl_set_id a8cdec12-81d1-4ef4-82c0-d05d93c37a07, 496b346b-ca79-4483-a950-bed9464e6a9d, 0fc3 ... Package NDC 68180-588-01, 68180-588-09, 68180-588-02, 68180-589-01, 68180-589-09, 68180-589- ... NUIN0000175562, N0000000181Established Pharmacologic ClassAngiotensin Converting Enzyme Inhibitor [EPC]Mechanism of ActionAngiotensin-converting Enzyme Inhibitors [MoA]UNIIL35JN3I7SJ

4)

drugcharacterization1medicinalproductSERTRALINEdrugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate10/12/2012drugenddateformat102drugenddate01/01/2014

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

5)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugadministrationroute065drugstartdateformat102drugstartdate28/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

6)

drugcharacterization1medicinalproductLIORESALdrugauthorizationnumb020075drugstructuredosagenumb207drugstructuredosageunit004drugadministrationroute037

activesubstance

activesubstancenameBACLOFEN

7)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext227.52 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate25/02/2014drugenddateformat102drugenddate26/02/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

8)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext274.29 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate11/03/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

9)

drugcharacterization1medicinalproductAMLODOPINEdrugstructuredosagenumb30drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate05/07/2012

activesubstance

activesubstancenameAMLODIPINE BESYLATE

10)

drugcharacterization1medicinalproductIBUPROFEN.drugstructuredosagenumb1200drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate09/01/2014

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

11)

drugcharacterization1medicinalproductSERTRALINEdrugadministrationroute065drugstartdateformat102drugstartdate07/02/2014drugenddateformat102drugenddate26/02/2014

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

12)

drugcharacterization1medicinalproductLIORESALdrugbatchnumbS0079drugauthorizationnumb020075drugadministrationroute037

activesubstance

activesubstancenameBACLOFEN

13)

drugcharacterization1medicinalproductPARACETAMOLdrugstructuredosagenumb1000drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate12/11/2012

activesubstance

activesubstancenameACETAMINOPHEN

14)

drugcharacterization1medicinalproductMIRTAZAPINE.drugstructuredosagenumb15drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate22/05/2014

activesubstance

activesubstancenameMIRTAZAPINE

openFDA Info on Medication

Application Number ANDA076541, ANDA076921, ANDA077376, ANDA205798, ANDA077666, NDA020415, NDA021208 ... Brand NameMIRTAZAPINE, REMERON, REMERONSOLTABGeneric NameMIRTAZAPINEManufacturers Northstar Rx LLC, Aurolife Pharma LLC, Sun Pharmaceutical Industries, Inc., Auro ... product_ndc 16714-706, 16714-707, 16714-708, 16714-709, 13107-001, 13107-031, 13107-003, 131 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINERXCUI 311725, 311726, 314111, 476809, 283406, 283407, 283485, 211322, 211323, 261135, ... spl_id 0506d20e-0f1c-4bd5-a298-383279478f20, ae272efb-da52-4ff3-9ea9-353cef42a174, 03b7 ... spl_set_id 0039f505-7cd0-4d79-b5dd-bf2d172571a0, aa05d606-29fd-443e-802b-1d65584d6bb1, f236 ... Package NDC 16714-706-01, 16714-707-01, 16714-708-01, 16714-709-01, 16714-709-02, 13107-001- ... UNIIA051Q2099Q

15)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext143.94 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate21/01/2014drugenddateformat102drugenddate22/01/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

16)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb60drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate20/01/2014drugenddateformat102drugenddate23/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

17)

drugcharacterization1medicinalproductMETOPROLOL.drugstructuredosagenumb300drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate05/07/2012

activesubstance

activesubstancenameMETOPROLOL

openFDA Info on Medication

Application NumberANDA078950, ANDA091045, ANDA202871Brand NameMETOPROLOL, METOPROLOL TARTRATEGeneric NameMETOPROLOL TARTRATE, METOPROLOLManufacturers Baxter Healthcare Corporation, Fresenius Kabi USA, LLC, Alembic Pharmaceuticals ... product_ndc 36000-033, 63323-660, 62332-112, 62332-113, 62332-114, 46708-290, 46708-291, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMETOPROLOL TARTRATERXCUI866508, 866511, 866514, 866924spl_id 202a1ff0-38f7-4bf2-ade7-6ede8fa64486, 94a4f468-def9-95b9-e053-2995a90a3428, bd31 ... spl_set_id 09566368-f91d-43a3-b683-30c844fb125a, be1c686e-37a5-4a53-945b-68a6ead35134, 2483 ... Package NDC 36000-033-10, 63323-660-05, 62332-112-30, 62332-112-31, 62332-112-91, 62332-113- ... UNIIW5S57Y3A5L

18)

drugcharacterization1medicinalproductPERINDOPRILdrugstructuredosagenumb4drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate05/07/2012drugenddateformat102drugenddate10/01/2014

activesubstance

activesubstancenamePERINDOPRIL

19)

drugcharacterization1medicinalproductSILDENAFIL.drugstructuredosagenumb50drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate20/02/2013

activesubstance

activesubstancenameSILDENAFIL

openFDA Info on Medication

Application Number ANDA203988, ANDA204883, ANDA201171, ANDA203962, ANDA202025, ANDA203623, ANDA2064 ... Brand NameSILDENAFIL, SILDENAFIL CITRATEGeneric NameSILDENAFIL CITRATE, SILDENAFIL, SILDINAFILManufacturers AuroMedics Pharma LLC, TruPharma LLC, Mylan Pharmaceuticals Inc., Aurobindo Phar ... product_ndc 55150-166, 52817-295, 0378-1658, 0378-1659, 0378-1660, 65862-689, 65862-690, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsSILDENAFIL CITRATE, SILDENAFILRXCUI882527, 577033, 312950, 314228, 314229, 1307427spl_id fa662b74-7d1b-4784-8a4c-0e2fc1ae2ddb, a8abd38f-2334-34e3-e053-2a95a90acb7d, 1d0e ... spl_set_id bb92d686-a81e-4b91-8048-693af0534cb3, c8864c64-22ad-402b-a1e8-cfb53fa02e80, cad6 ... Package NDC 55150-166-13, 52817-295-90, 52817-295-00, 0378-1658-93, 0378-1658-01, 0378-1658- ... UNIIBW9B0ZE037, 3M7OB98Y7HNUIN0000175599, N0000020026Established Pharmacologic ClassPhosphodiesterase 5 Inhibitor [EPC]Mechanism of ActionPhosphodiesterase 5 Inhibitors [MoA]

20)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext297.42 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate31/01/2014drugenddateformat102drugenddate03/02/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

21)

drugcharacterization1medicinalproductLIORESALdrugauthorizationnumb020075drugstructuredosagenumb100drugstructuredosageunit004drugadministrationroute037

activesubstance

activesubstancenameBACLOFEN

22)

drugcharacterization1medicinalproductZOPICLONEdrugdosagetext3.75 MGdrugadministrationroute048drugstartdateformat102drugstartdate20/02/2013

activesubstance

activesubstancenameZOPICLONE

23)

drugcharacterization1medicinalproductVENLAFAXINE 25 MG TEVAdrugstructuredosagenumb75drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate26/02/2014

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

24)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugadministrationroute065drugstartdateformat102drugstartdate31/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

25)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugadministrationroute048drugstartdateformat102drugstartdate11/03/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

26)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb30drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate01/08/2012drugenddateformat102drugenddate20/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

27)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb10drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate28/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

28)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb10drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate31/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

29)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb10drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate31/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

30)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb100drugstructuredosageunit004drugadministrationroute042drugstartdateformat102drugstartdate17/01/2014drugenddateformat102drugenddate19/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

31)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext172.03 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate22/01/2014drugenddateformat102drugenddate23/01/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

32)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext207.44 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate23/01/2014drugenddateformat102drugenddate27/01/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

33)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugstructuredosagenumb60drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate01/08/2012

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

34)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugadministrationroute065drugstartdateformat102drugstartdate23/01/2014

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

35)

drugcharacterization1medicinalproductLIORESALdrugbatchnumbS0079drugauthorizationnumb020075drugadministrationroute037

activesubstance

activesubstancenameBACLOFEN

36)

drugcharacterization1medicinalproductLIORESALdrugbatchnumbS0076drugauthorizationnumb020075drugdosagetext274.29 MCG/DAY)drugadministrationroute037

activesubstance

activesubstancenameBACLOFEN

37)

drugcharacterization1medicinalproductCO-DYDRAMOLdrugstructuredosagenumb2000drugstructuredosageunit003drugadministrationroute048drugstartdateformat102drugstartdate09/01/2014

activesubstance

activesubstancenameACETAMINOPHEN\DIHYDROCODEINE

38)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext120.13 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate20/01/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

39)

drugcharacterization1medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext249.98 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate26/02/2014drugenddateformat102drugenddate11/03/2014actiondrug3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

40)

drugcharacterization1medicinalproductFLUCLOXACILLIN 2014/02/23drugstructuredosagenumb2drugstructuredosageunit003drugadministrationroute042drugstartdateformat102drugstartdate23/02/2014drugenddateformat102drugenddate26/02/2014

activesubstance

activesubstancenameFLUCLOXACILLIN

41)

drugcharacterization2medicinalproductBACLOFEN.drugauthorizationnumb020075drugdosagetext248.72 MCG/DAYdrugadministrationroute037drugstartdateformat102drugstartdate28/01/2014drugenddateformat102drugenddate30/01/2014actiondrug4

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA074584, NDA020075, ANDA209102, ANDA209594, ANDA21004 ... Brand NameBACLOFEN, LIORESAL (BACLOFEN), BACLOFEN (INTRATHECAL), OZOBAXGeneric NameBACLOFENManufacturers Northstar RxLLC, Upsher-Smith Laboratories, LLC, Saol Therapeutics Inc., TruPhar ... product_ndc 16714-071, 16714-072, 0832-1024, 0832-1025, 70257-560, 70257-561, 70257-563, 702 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 308516, 308517, 805678, 805679, 1666613, 1666620, 1666622, 16666 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, 44afdf24-9775-4730-af93-82564899d921, 6cbc ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 29af8fe6-66ca-4575-b0ef-cd3a63d80924, 4e47 ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 0832-1024-09, 0832-1024- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

summary

narrativeincludeclinicalCASE EVENT DATE: 20130220

Report Duplicate

duplicatesourceMEDTRONICduplicatenumbADR-2014-01062

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use