Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10143652serious1Date Last Updated30/04/2014receiptdateformat102companynumbUS-PFIZER INC-2014116628occurcountryUSseriousnessother1duplicate1Date Received30/04/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age37Unit of Onset AgeyearsWeight58.96SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionConvulsionOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionSpinal fractureOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionFemur fractureOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionAnkle fractureOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionWrist fractureOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionLigament sprainOutcomeUnknown

7)

reactionmeddraversionpt17.1ReactionIntentional product misuseOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionPyrexiaOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionSomnolenceOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionMood alteredOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionIrritabilityOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionNauseaOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionVomitingOutcomeUnknown

15)

reactionmeddraversionpt17.0ReactionTremorOutcomeUnknown

16)

reactionmeddraversionpt17.0ReactionMalaiseOutcomeUnknown

17)

reactionmeddraversionpt17.0ReactionMovement disorderOutcomeUnknown

18)

reactionmeddraversionpt17.0ReactionDrug intoleranceOutcomeUnknown

19)

reactionmeddraversionpt17.0ReactionHeadacheOutcomeUnknown

20)

reactionmeddraversionpt17.0ReactionVisual impairmentOutcomeUnknown

21)

reactionmeddraversionpt17.0ReactionCryingOutcomeUnknown

22)

reactionmeddraversionpt17.0ReactionConcussionOutcomeUnknown

23)

reactionmeddraversionpt17.0ReactionFeeling abnormalOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 3X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationNERVE INJURYdrugstartdateformat602drugstartdate//2014actiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

2)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationCONVULSIONactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

3)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationSPINAL DISORDERactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

4)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationPANIC ATTACKactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

5)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationANXIETYactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

6)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationSPINAL COLUMN STENOSISactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

7)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationOSTEOARTHRITISactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

8)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationTRICUSPID VALVE DISEASEactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

9)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationINSOMNIAactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

10)

drugcharacterization1medicinalproductALPRAZOLAMdrugauthorizationnumb018276drugdosageformTABLETdrugindicationMULTIPLE SCLEROSISactiondrug4

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA078088 ... Brand Name ALPRAZOLAM, XANAX XR, ALPRAZOLAM ER, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZO ... Generic NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, ... spl_id 05c4e062-e29d-4e46-a6f0-302025edd596, 84ebf58b-deef-4f35-ba5e-e901288c2997, 3889 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

11)

drugcharacterization2medicinalproductZIPSORdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, 3X/DAYdrugindicationANTIINFLAMMATORY THERAPY

openFDA Info on Medication

Application NumberNDA022202Brand NameZIPSORGeneric NameDICLOFENAC POTASSIUMManufacturersAssertio Therapeutics, Inc.product_ndc13913-008Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDICLOFENAC POTASSIUMRXCUI858342, 858346spl_idb1ec6421-7dd9-455c-956f-e522dfe302f0spl_set_idc982eca0-fc41-11e1-a9c8-0002a5d5c51bPackage NDC13913-008-11, 13913-008-12, 13913-008-94UNIIL4D5UA6CB4

12)

drugcharacterization2medicinalproductZIPSORdrugindicationMUSCLE SPASMS

openFDA Info on Medication

Application NumberNDA022202Brand NameZIPSORGeneric NameDICLOFENAC POTASSIUMManufacturersAssertio Therapeutics, Inc.product_ndc13913-008Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDICLOFENAC POTASSIUMRXCUI858342, 858346spl_idb1ec6421-7dd9-455c-956f-e522dfe302f0spl_set_idc982eca0-fc41-11e1-a9c8-0002a5d5c51bPackage NDC13913-008-11, 13913-008-12, 13913-008-94UNIIL4D5UA6CB4

13)

drugcharacterization2medicinalproductGABAPENTINdrugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, 3X/DAYdrugindicationCONVULSION

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

14)

drugcharacterization2medicinalproductGABAPENTINdrugindicationNERVE INJURY

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 6e41ce47-a6cc-4c34-84f1-305747df38c2, 5fc4 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

15)

drugcharacterization2medicinalproductPERCOCETdrugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext325/10MG, 4X/DAY

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, ACETAMINOPHENRXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNII362O9ITL9D, C1ENJ2TE6C

16)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, 1X/DAYdrugindicationBIPOLAR I DISORDER

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

17)

drugcharacterization2medicinalproductZOLOFTdrugindicationPOST-TRAUMATIC STRESS DISORDER

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

18)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, 3X/DAYdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat602drugstartdate//2009drugenddateformat602drugenddate//2014

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

19)

drugcharacterization2medicinalproductXANAXdrugindicationLUMBAR SPINAL STENOSIS

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

20)

drugcharacterization2medicinalproductXANAXdrugindicationOSTEOARTHRITIS

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

21)

drugcharacterization2medicinalproductXANAXdrugindicationNERVE INJURY

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

22)

drugcharacterization2medicinalproductXANAXdrugindicationTRICUSPID VALVE DISEASE

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

23)

drugcharacterization2medicinalproductXANAXdrugindicationINSOMNIA

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

24)

drugcharacterization2medicinalproductXANAXdrugindicationCONVULSION

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

25)

drugcharacterization2medicinalproductXANAXdrugindicationPANIC ATTACK

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

26)

drugcharacterization2medicinalproductXANAXdrugindicationANXIETY

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMspl_id3889a3af-7247-42d4-ae83-aaee653ae3ba, 4c17a130-5c22-4228-a8ef-86744334edcfspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

27)

drugcharacterization2medicinalproductTEMAZEPAMdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 MG, 1X/DAYdrugindicationINSOMNIA

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA078581, ANDA0711 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id c21455f5-1c17-442d-b1d1-69d27d290d48, eac383e8-6227-4439-b72d-c1b1794ee031, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

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