Adverse Event Report

Report

reporttype2Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10063864serious1Date Last Updated07/08/2014receiptdateformat102companynumbUS-BIOGENIDEC-2014BI031928occurcountryUSduplicate1Date Received08/04/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age42Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionCrohn^s diseaseOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.1ReactionPneumoniaOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionPostictal headacheOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.1ReactionVomitingOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt17.1ReactionAphagiaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt17.1ReactionConvulsionOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.1ReactionHemiparesisOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductDRISDOLdrugstructuredosagenumb50000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformCAPSULEdrugadministrationroute048drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberNDA003444Brand NameDRISDOLGeneric NameERGOCALCIFEROLManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-493Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410, 1367416spl_id9ffcac9b-b70e-40ec-a258-9d739771bdbaspl_set_idacb61678-d23d-405d-8c14-1a16cfd3a776Package NDC30698-493-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

2)

drugcharacterization2medicinalproductPERI-COLACEdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate24/10/2012drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameCASANTHRANOL\DOCUSATE SODIUM

3)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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

4)

drugcharacterization2medicinalproductNORCOdrugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate24/07/2013drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application NumberANDA040099, ANDA040148Brand NameNORCOGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAllergan, Inc.product_ndc0023-6002, 0023-6021, 0023-6022Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCODONE BITARTRATE, ACETAMINOPHENRXCUI856999, 857001, 857002, 857004, 857005, 857007spl_id801535a8-4c58-4a32-9c8f-df02584b8d13spl_set_id66a328bc-055f-4107-8b81-f6f939bea0a7Package NDC0023-6002-01, 0023-6021-01, 0023-6021-05, 0023-6022-01, 0023-6022-05UNII362O9ITL9D, NO70W886KK

5)

drugcharacterization2medicinalproductSCOPOLAMINEdrugstructuredosagenumb1drugstructuredosageunit003drugdosageformTRANSDERMAL PATCHdrugadministrationroute061drugstartdateformat102drugstartdate15/10/2012drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameSCOPOLAMINE

openFDA Info on Medication

Application NumberANDA203753, NDA017874, ANDA212342Brand NameSCOPOLAMINE, TRANSDERM SCOPGeneric NameSCOPOLAMINEManufacturers Mylan Pharmaceuticals Inc., GlaxoSmithKline Consumer Healthcare Holdings (US) LL ... product_ndc0378-6470, 0067-4346, 50742-505, 66758-208Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsSCOPOLAMINERXCUI226552, 351875spl_id 163accb7-45e6-4d97-844d-72b606677008, eb0551ff-0330-49f7-8876-e75cae97646a, 0b51 ... spl_set_id 163accb7-45e6-4d97-844d-72b606677008, 7192d89d-ea4b-42b0-b8c1-e7fd41be8a0a, 2a6f ... Package NDC 0378-6470-16, 0378-6470-99, 0378-6470-97, 0378-6470-44, 0067-4346-04, 0067-4346- ... NUIN0000175574, N0000175370Established Pharmacologic ClassAnticholinergic [EPC]Mechanism of ActionCholinergic Antagonists [MoA]UNIIDL48G20X8X

6)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugstartdateformat102drugstartdate09/10/2012drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022101, NDA021957, NDA021153, NDA021689Brand NameNEXIUM, NEXIUM I.V.Generic NameESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0186-4010, 0186-5020, 0186-4020, 0186-4040, 0186-5040, 0186-4025, 0186-4050, 018 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE SODIUMspl_id3797ceb7-550b-4e9a-8314-8e1e4995360b, ac4ba22b-f431-4ab4-b239-0e220ad804ddspl_set_idf4853677-1622-4037-688b-fdf533a11d96, c325bbfc-46f3-471e-7bbc-ed0d6965d13bPackage NDC 0186-5020-31, 0186-5020-54, 0186-5020-82, 0186-4010-01, 0186-4010-02, 0186-4020- ... UNIIR6DXU4WAY9, L2C9GWQ43HRXCUI486501, 603536

7)

drugcharacterization2medicinalproductFERROUS SULFATEdrugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameFERROUS SULFATE\FERROUS SULFATE, DRIED

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATE, IRON SUPPLEMENT THERAPYManufacturers Richmond Pharmaceuticals, Inc., Boiron, Healthlife of USA, Washington Homeopathi ... product_ndc54738-963, 0220-2111, 69517-133, 68428-941, 71919-293Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 655e ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 3810 ... Package NDC 54738-963-01, 54738-963-03, 0220-2111-41, 69517-133-30, 68428-941-03, 68428-941- ... UNII39R4TAN1VT

8)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, NDA208401, ANDA078402, ANDA212041, ANDA076180, ANDA07616 ... Brand NameLISINOPRIL, QBRELIS, PRINIVIL, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Azurity Pharmac ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 526 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 1806884, 1806890, 205326, 311353, 206764, 206765 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, 2fdc ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, 9f6e ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

9)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb20drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate15/10/2012drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA040584, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., GeneYork Pharmaceuticals Group LLC, Mylan Pharma ... product_ndc 75987-020, 75987-021, 75987-022, 71329-106, 0378-0640, 0378-0641, 0378-0642, 060 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id be29c86d-242b-42a7-9488-ecf6f76426cd, 4384c1d1-059b-4689-9f3d-1078de814ce8, 88a6 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, be50449f-3aa8-46b7-9246-2dbd5f04f2b1, fec0 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

10)

drugcharacterization2medicinalproductTIROSINTdrugstructuredosagenumb100drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021924, NDA206977Brand NameTIROSINT, TIROSINT SOLGeneric NameLEVOTHYROXINE SODIUMManufacturersIBSA Pharma Inc.product_ndc 71858-0005, 71858-0010, 71858-0015, 71858-0020, 71858-0025, 71858-0030, 71858-00 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 905451, 905453, 905455, 905457, 905458, 905460, 905462, 905464, 966404, 966405, ... spl_idf1716939-50f1-40fa-9305-8fad0f17d5cd, c47e575d-10bb-4567-ab94-34745c6a80f3spl_set_id7a7ade79-0165-4e31-b84e-667416c00c7e, 5d378add-f13d-40f2-99dc-0f2340ab44b7Package NDC 71858-0005-4, 71858-0005-1, 71858-0010-4, 71858-0010-1, 71858-0015-4, 71858-0015 ... UNII9J765S329G

11)

drugcharacterization1medicinalproductTYSABRIdrugauthorizationnumb125104drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosageformINTRAVENOUS INFUSIONdrugadministrationroute042drugindicationCROHN^S DISEASEactiondrug4

activesubstance

activesubstancenameNATALIZUMAB

openFDA Info on Medication

Application NumberBLA125104Brand NameTYSABRIGeneric NameNATALIZUMABManufacturersBiogen Inc.product_ndc64406-008Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsNATALIZUMABRXCUI477484, 603541spl_id7628d515-59db-47b7-8ba9-95dc94363af5spl_set_idc5fdde91-1989-4dd2-9129-4f3323ea2962Package NDC64406-008-01NUIN0000175775, N0000175774Established Pharmacologic ClassIntegrin Receptor Antagonist [EPC]Mechanism of ActionIntegrin Receptor Antagonists [MoA]UNII3JB47N2Q2P

12)

drugcharacterization1medicinalproductTYSABRIdrugauthorizationnumb125104drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosageformINTRAVENOUS INFUSIONdrugadministrationroute042drugindicationCROHN^S DISEASEdrugstartdateformat102drugstartdate07/01/2013actiondrug4

activesubstance

activesubstancenameNATALIZUMAB

openFDA Info on Medication

Application NumberBLA125104Brand NameTYSABRIGeneric NameNATALIZUMABManufacturersBiogen Inc.product_ndc64406-008Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsNATALIZUMABRXCUI477484, 603541spl_id7628d515-59db-47b7-8ba9-95dc94363af5spl_set_idc5fdde91-1989-4dd2-9129-4f3323ea2962Package NDC64406-008-01NUIN0000175775, N0000175774Established Pharmacologic ClassIntegrin Receptor Antagonist [EPC]Mechanism of ActionIntegrin Receptor Antagonists [MoA]UNII3JB47N2Q2P

13)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

14)

drugcharacterization2medicinalproductZOFRANdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb8drugintervaldosagedefinition805drugadministrationroute048

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

15)

drugcharacterization2medicinalproductZANAFLEXdrugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate16/10/2012drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameTIZANIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020397, NDA021447Brand NameZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturersCovis Pharmaproduct_ndc70515-594, 70515-602, 70515-604, 70515-606Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211spl_id8f9774b0-1a53-4e5e-913b-d9f0055e8daaspl_set_id043d9e51-bfa2-4add-9058-5ece332f7e99Package NDC70515-602-15, 70515-604-15, 70515-606-15, 70515-594-15UNIIB53E3NMY5C

16)

drugcharacterization2medicinalproductBUTALBITAL, ASPIRIN AND CAFFEINEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb4drugintervaldosagedefinition805drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameASPIRIN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberANDA086996, ANDA204195, NDA017534Brand NameBUTALBITAL, ASPIRIN, AND CAFFEINE, BUTALBITAL, ASPIRIN AND CAFFEINE, FIORINALGeneric NameBUTALBITAL, ASPIRIN, AND CAFFEINE, BUTALBITAL, ASPIRIN AND CAFFEINEManufacturers Lannett Company, Inc., Vensun Pharmaceuticals, Inc., Actavis Pharma, Inc., Aller ... product_ndc0527-1552, 42543-098, 0591-3219, 0023-6146Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUTALBITAL, ASPIRIN, CAFFEINERXCUI238134, 238135, 211310spl_id 5e652198-4ba3-4f76-8836-d502d9847118, 192e71b5-d399-4698-88bf-534ff69d7393, c912 ... spl_set_id ba60b130-33cd-4db9-92a7-2cab8ded0737, ce47777f-8cf7-4f53-b48f-165b83516896, e310 ... Package NDC0527-1552-01, 42543-098-01, 0591-3219-01, 0023-6146-01NUI N0000175693, M0002177, N0000000160, N0000008836, M0001335, N0000175722, N0000175 ... Established Pharmacologic Class Barbiturate [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregati ... Chemical StructureBarbiturates [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... UNIIKHS0AZ4JVK, R16CO5Y76E, 3G6A5W338E

17)

drugcharacterization2medicinalproductBACLOFEN.drugstructuredosagenumb10drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048

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

18)

drugcharacterization2medicinalproductTOPAMAXdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application NumberNDA020505, NDA020844Brand NameTOPAMAXGeneric NameTOPIRAMATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-639, 50458-640, 50458-641, 50458-642, 50458-647, 50458-645Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, ... spl_id97a88b90-639a-11ea-a5cc-2737fc2ca371spl_set_id21628112-0c47-11df-95b3-498d55d89593Package NDC 50458-639-65, 50458-640-65, 50458-641-65, 50458-642-65, 50458-647-65, 50458-645- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

19)

drugcharacterization2medicinalproductNORVASCdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate10/10/2012drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id3f5ca9a3-9076-49ab-b247-669c337f3364spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

20)

drugcharacterization2medicinalproductDIAZEPAM.drugstructuredosagenumb5drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate23/07/2013drugenddateformat102drugenddate23/06/2014

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMspl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 26b3 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TURXCUI197589, 197590, 197591, 2120550, 801957, 801961, 801966, 309843, 309844, 309845

summary

narrativeincludeclinicalCASE EVENT DATE: 201402

Report Duplicate

duplicatesourceBIOGENduplicatenumbUS-BIOGENIDEC-2014BI031928

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use