Adverse Event Report

Report

Version of Safety Report ID4Safety Report ID10489985primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/05/2016reporttype1serious2receivedateformat102Date Received02/10/2014receiptdateformat102Date Last Updated18/01/2016fulfillexpeditecriteria2companynumbUS-PFIZER INC-2014270324duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014270324

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age51Unit of Onset AgeyearsSexFemale

Contents

Reaction

1)

reactionmeddraversionpt19.0ReactionAstheniaOutcomeUnknown

2)

reactionmeddraversionpt19.0ReactionFatigueOutcomeUnknown

3)

reactionmeddraversionpt19.0ReactionPainOutcomeUnknown

4)

reactionmeddraversionpt19.0ReactionFungal skin infectionOutcomeUnknown

5)

reactionmeddraversionpt19.0ReactionMusculoskeletal discomfortOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductCHLORDIAZEPOXIDE/CLIDINIUMdrugdosagetext5MG-2, UNK

2)

drugcharacterization2medicinalproductOS-CAL + DdrugdosagetextUNK

3)

drugcharacterization2medicinalproductFLUCONAZOLE.drugdosagetextUNK

activesubstance

activesubstancenameFLUCONAZOLE

openFDA Info on Medication

Application Number ANDA208963, ANDA076658, ANDA076957, ANDA077731, ANDA077253, ANDA076766, ANDA0767 ... Brand NameFLUCONAZOLE, DIFLUCANGeneric NameFLUCONAZOLEManufacturers Cadila Healthcare Limited, Dr. Reddy's Laboratories Limited, Rising Pharmaceutic ... product_ndc 70771-1063, 70771-1064, 70771-1065, 70771-1066, 55111-143, 55111-144, 55111-145, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFLUCONAZOLERXCUI 197698, 197699, 197700, 197701, 1721314, 1721315, 310352, 310353, 201900, 201901 ... spl_id 671a4cc4-0b0f-4d27-b472-482f9901656a, 54d57030-5a06-e3d5-ea3e-902dc0b19cf9, c626 ... spl_set_id 0adb2f88-8a6f-4f33-9e2d-73f537e05313, d7fa1d79-4cd3-4a55-b74b-b31e82e616a3, 4f97 ... Package NDC 70771-1063-3, 70771-1063-1, 70771-1063-5, 70771-1063-4, 70771-1064-3, 70771-1064 ... NUIN0000175487, M0002083, N0000182140, N0000182141, N0000185504Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cyt ... UNII8VZV102JFY

4)

drugcharacterization2medicinalproductDENAVIRdrugdosagetextUNKdrugdosageformCREAM

activesubstance

activesubstancenamePENCICLOVIR

openFDA Info on Medication

Application NumberNDA020629Brand NameDENAVIRGeneric NamePENCICLOVIRManufacturersMylan Pharmaceuticals Inc.product_ndc0378-9720Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsPENCICLOVIRRXCUI211343, 312255spl_ided286bc3-dda6-4f75-9338-3eb0987a2a7dspl_set_id61229829-55a0-4d6f-a423-4b48a2b4d8e5Package NDC0378-9720-55NUIN0000020060, N0000175468, N0000175459Mechanism of ActionDNA Polymerase Inhibitors [MoA]Established Pharmacologic ClassHerpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]UNII359HUE8FJC

5)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNK

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

6)

drugcharacterization2medicinalproductCRESTORdrugdosagetextUNK

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

7)

drugcharacterization2medicinalproductACTOSdrugdosagetextUNK

activesubstance

activesubstancenamePIOGLITAZONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021073Brand NameACTOSGeneric NamePIOGLITAZONEManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-151, 64764-301, 64764-451Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPIOGLITAZONE HYDROCHLORIDERXCUI261266, 261267, 261268, 312440, 312441, 317573spl_id73a4f7c2-69a0-4696-9d58-73e39a891241spl_set_idd2ddc491-88a9-4063-9150-443b4fa4330cPackage NDC 64764-151-04, 64764-151-05, 64764-151-06, 64764-151-02, 64764-301-14, 64764-301- ... UNIIJQT35NPK6C

8)

drugcharacterization2medicinalproductPRILOSECdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNK

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharma US, Incproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_idba93d1bb-75ca-407c-b2e0-9aa66d8eed84spl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

9)

drugcharacterization2medicinalproductAZATHIOPRINE.drugdosagetextUNK

activesubstance

activesubstancenameAZATHIOPRINE

openFDA Info on Medication

Application NumberANDA074069, ANDA075252, ANDA077621, NDA016324, ANDA208687Brand NameAZATHIOPRINE, AZASAN, IMURANGeneric NameAZATHIOPRINEManufacturers AvKARE, Salix Pharmaceuticals, Cadila Healthcare Limited, Zydus Pharmaceuticals ... product_ndc 42291-071, 65649-231, 65649-241, 65841-602, 68382-118, 68382-119, 68382-120, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAZATHIOPRINERXCUI197388, 359228, 359229, 404475, 404476, 199310, 105611spl_id d6691c4a-9206-34b7-e053-2995a90a1710, d8b666ee-9db9-db2f-e053-2995a90ae274, b999 ... spl_set_id d4c7d621-9642-4027-e053-2995a90a9220, 9050af7a-19c6-4670-937a-9445605de995, d65b ... Package NDC 42291-071-01, 65649-231-41, 65649-241-41, 65841-602-01, 65841-602-05, 68382-118- ... NUIN0000000233, M0015066, N0000175712, M0018169Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Chemical StructureNucleosides [CS], Purines [CS]Established Pharmacologic ClassPurine Antimetabolite [EPC]UNIIMRK240IY2L

10)

drugcharacterization2medicinalproductPROCTOSOLdrugdosagetextUNK

11)

drugcharacterization2medicinalproductKLOR-CONdrugdosagetextUNK

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Application NumberNDA019123, ANDA209662Brand NameKLOR-CONGeneric NamePOTASSIUM CHLORIDEManufacturersUpsher-Smith Laboratories, LLCproduct_ndc0245-5315, 0245-5316, 0245-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CHLORIDERXCUI312529, 628953, 628958, 832718, 1867544, 1867547spl_id0907ea1c-82f3-4ba8-9d1b-3f4fa104d7a2, d9472735-27e8-4597-92f4-0b9afaaaa0a4spl_set_id1ff53330-065c-4213-9c0c-ac498621d09d, e61a4522-b91d-400a-952c-6f035e4610ddPackage NDC 0245-5315-11, 0245-5315-15, 0245-5315-89, 0245-5315-01, 0245-5316-11, 0245-5316- ... UNII660YQ98I10

12)

drugcharacterization2medicinalproductIMODIUMdrugdosagetextUNK

activesubstance

activesubstancenameLOPERAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075232, NDA019487, NDA021140Brand NameIMODIUM A-D, IMODIUM MULTI-SYMPTOM RELIEFGeneric NameLOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-317, 50580-134, 50580-338Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLOPERAMIDE HYDROCHLORIDE, DIMETHICONERXCUI978010, 978013, 1250685, 1250693, 978001, 1426827spl_id cd230883-bf53-7a6c-e053-2a95a90aefee, daf73f04-740b-3bbf-e053-2a95a90ac408, dfe6 ... spl_set_id 01da76d0-1979-4c45-9d39-c72ae4e4ffe2, 76a976d5-8bee-4158-a94d-7fbfc5544fd4, ecb9 ... Package NDC 50580-317-01, 50580-317-03, 50580-317-04, 50580-317-05, 50580-317-06, 50580-134- ... UNII77TI35393C, 92RU3N3Y1ONUIN0000010282Physiologic/Pharmacodynamic EffectSkin Barrier Activity [PE]

13)

drugcharacterization1medicinalproductXELJANZdrugauthorizationnumb203214drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, 2X/DAYdrugdosageformTABLETdrugadministrationroute048drugindicationRHEUMATOID ARTHRITISdrugstartdateformat610drugstartdate/07/2014actiondrug5

activesubstance

activesubstancenameTOFACITINIB CITRATE

openFDA Info on Medication

Application NumberNDA208246, NDA203214, NDA213082Brand NameXELJANZ XR, XELJANZGeneric NameTOFACITINIBManufacturersPfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0069-0501, 0069-1001, 0069-1002, 0069-0502, 0069-1029, 63539-012, 63539-501, 635 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOFACITINIB CITRATERXCUI 1357541, 1357547, 1741046, 1741049, 2048566, 2048568, 2273113, 2273115, 2478433, ... spl_id597b664d-aca6-41a9-a4f3-da48832fbbe3, 2cf76400-3562-4784-bf79-10e93a60d0fespl_set_idcf74ba2f-afc5-4baa-8594-979c889a5831, 68e3d6b2-7838-4d2d-a417-09d919b43e13Package NDC 0069-1001-01, 0069-0501-30, 0069-1002-01, 0069-0502-30, 0069-1029-01, 0069-1029- ... UNIIO1FF4DIV0D

14)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb1drugstructuredosageunit003drugdosagetext1 MG, UNK

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... 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

15)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNK

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

16)

drugcharacterization2medicinalproductVITAMIN B12drugdosagetextUNK

activesubstance

activesubstancenameCYANOCOBALAMIN

17)

drugcharacterization2medicinalproductVITAMIN D3drugdosagetextUNK

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

18)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNK

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

19)

drugcharacterization2medicinalproductVANCOMYCIN HYDROCHLORIDE.drugstructuredosagenumb125drugstructuredosageunit003drugdosagetext125 MG, UNK

activesubstance

activesubstancenameVANCOMYCIN HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA062663, ANDA210729, ANDA091532, ANDA063076, ANDA204107, NDA050671, ANDA20578 ... Brand NameVANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, VANCOCIN, FIRVANQGeneric NameVANCOMYCIN HYDROCHLORIDE, VANCOMYCINManufacturers Fresenius Kabi USA, LLC, Pharmaceutical Associates, Inc., SAMSON MEDICAL TECHNOL ... product_ndc 63323-284, 0121-0867, 0121-0890, 66288-7100, 0409-5017, 0409-6509, 63323-221, 03 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsVANCOMYCIN HYDROCHLORIDE, VANCOMYCINRXCUI 1807513, 313570, 313571, 239209, 313572, 1807516, 1807508, 1807510, 1807511, 180 ... spl_id 94a2bef0-c803-5ce1-e053-2995a90a1c11, d741fdbf-05e2-581b-e053-2995a90a7fbe, d607 ... spl_set_id 83ea3faf-fedd-4725-911f-d71a23ec5d5e, 8eacc01c-5ce6-1869-e053-2a95a90a57ce, 9358 ... Package NDC 63323-284-21, 0121-0867-20, 0121-0890-20, 66288-7100-1, 0409-6509-49, 0409-5017- ... UNII71WO621TJD, 6Q205EH1VUNUIN0000175491, M0009481Established Pharmacologic ClassGlycopeptide Antibacterial [EPC]Chemical StructureGlycopeptides [CS]

20)

drugcharacterization2medicinalproductASACOL HDdrugstructuredosagenumb800drugstructuredosageunit003drugdosagetext800 MG, UNK

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA021830Brand NameASACOL HDGeneric NameMESALAMINEManufacturersAllergan, Inc.product_ndc0023-5901Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMESALAMINERXCUI833234, 849383spl_idb9e278fa-cfd6-4769-a5c2-d497adfe3fbespl_set_id2f68f68c-58d2-4575-b573-f2e62f95d7e3Package NDC0023-5901-18NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

21)

drugcharacterization2medicinalproductVALACICLOVIRdrugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, UNK

activesubstance

activesubstancenameVALACYCLOVIR HYDROCHLORIDE

22)

drugcharacterization2medicinalproductFORTEOdrugdosagetextUNK

activesubstance

activesubstancenameTERIPARATIDE

openFDA Info on Medication

Application NumberNDA021318Brand NameFORTEOGeneric NameTERIPARATIDEManufacturersEli Lilly and Companyproduct_ndc0002-8400Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsTERIPARATIDERXCUI1435115, 1435117spl_id1eae52b9-257b-4ef7-9fe3-b4110d7cf980spl_set_idaae667c5-381f-4f92-93df-2ed6158d07b0Package NDC0002-8400-01NUIM0015931, N0000180852Chemical StructureParathyroid Hormone [CS]Established Pharmacologic ClassParathyroid Hormone Analog [EPC]UNII10T9CSU89I

23)

drugcharacterization2medicinalproductSPIRONOLACTONE.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNK

activesubstance

activesubstancenameSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, ANDA202187, ANDA089424, ANDA2059 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096, 200817, 200820, 200825spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, c2d4 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

24)

drugcharacterization2medicinalproductNOVOLOGdrugdosagetextUNK (100/ML)

activesubstance

activesubstancenameINSULIN ASPART

openFDA Info on Medication

Application NumberBLA020986Brand NameNOVOLOGGeneric NameINSULIN ASPARTManufacturersNovo Nordiskproduct_ndc0169-2100, 0169-7501, 0169-3303, 0169-6339, 0169-6338, 0169-2001, 0169-2101Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsINSULIN ASPARTRXCUI311040, 351926, 1653196, 1653198, 1653202, 1653204spl_id7eb8d829-26ee-4a7a-8781-1f7fd6e3a832spl_set_id3a1e73a2-3009-40d0-876c-b4cb2be56fc5Package NDC 0169-7501-11, 0169-7501-90, 0169-3303-12, 0169-3303-91, 0169-3303-90, 0169-6339- ... NUIM0011417, N0000175453Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin Analog [EPC]UNII059QF0KO0R, D933668QVX

25)

drugcharacterization2medicinalproductMETANXdrugdosagetextUNK

activesubstance

activesubstancenameLEVOMEFOLATE CALCIUM\METHYLCOBALAMIN\PYRIDOXAL PHOSPHATE ANHYDROUS

26)

drugcharacterization2medicinalproductNITROFURANTOIN MONO-MACdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNK

27)

drugcharacterization2medicinalproductGABAPENTIN.drugdosagetextUNK

activesubstance

activesubstancenameGABAPENTIN

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, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... 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

28)

drugcharacterization2medicinalproductHYZAAR

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\LOSARTAN POTASSIUM

openFDA Info on Medication

Application NumberNDA020387Brand NameHYZAARGeneric NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEManufacturersOrganon LLCproduct_ndc78206-139, 78206-140, 78206-141Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUMspl_id07563f48-22cc-4178-b915-d156b4c4bf25spl_set_id4116ccde-2e23-45f4-b12f-6337df877744Package NDC 78206-139-01, 78206-139-02, 78206-140-01, 78206-140-02, 78206-141-01, 78206-141- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII3ST302B24A, 0J48LPH2TH

29)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb100drugstructuredosageunit004drugdosagetext100 UG, UNK

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

30)

drugcharacterization2medicinalproductENTOCORT ECdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MG, UNK

activesubstance

activesubstancenameBUDESONIDE

31)

drugcharacterization2medicinalproductDIPHENOXYLATE W/ATROPINE SULFATEdrugdosagetext2.5-0.02, UNK

activesubstance

activesubstancenameATROPINE SULFATE\DIPHENOXYLATE

32)

drugcharacterization2medicinalproductPROAIR HFAdrugstructuredosagenumb90drugstructuredosageunit004drugdosagetext90 UG, UNK

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application NumberNDA021457Brand NamePROAIR HFAGeneric NameALBUTEROL SULFATEManufacturersTeva Respiratory, LLCproduct_ndc59310-579Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI745752, 2123072spl_id07738d64-2ab5-4f96-bce1-f92bbb93ef18spl_set_id8e701d71-1dcb-4b84-bada-84e4f04f5e62Package NDC59310-579-22, 59310-579-23UNII021SEF3731

33)

drugcharacterization2medicinalproductASAdrugdosagetextUNK

activesubstance

activesubstancenameASPIRIN

34)

drugcharacterization2medicinalproductADVAIR HFAdrugdosagetextUNK

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id717071a8-e206-47f6-8e3f-c395d532ebd3spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNII6EW8Q962A5, O2GMZ0LF5W

35)

drugcharacterization2medicinalproductEFFEXORdrugstructuredosagenumb37.5drugstructuredosageunit003drugdosagetext37.5 MG, UNK

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

36)

drugcharacterization2medicinalproductLASIXdrugstructuredosagenumb80drugstructuredosageunit003drugdosagetext80 MG, UNK

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

37)

drugcharacterization2medicinalproductLORTABdrugdosagetext10MG-50, UNK

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application NumberANDA040881Brand NameLORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAkornproduct_ndc17478-450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, HYDROCODONE BITARTRATERXCUI1044427, 1442445spl_id912e747f-d400-4690-bf7a-d541f6ea6254spl_set_id21def91d-b6e3-4dde-983c-6925aedf0df0Package NDC17478-450-16UNII362O9ITL9D, NO70W886KK

38)

drugcharacterization2medicinalproductLIDOCAINE.drugstructuredosagenumb5drugstructuredosageunit030drugdosagetext5 %, UNK

activesubstance

activesubstancenameLIDOCAINE

openFDA Info on Medication

Application Number ANDA208822, part348, ANDA088586, part346, ANDA040911, ANDA206297, ANDA206498, AN ... Brand Name LIDOCAINE, LIDOCAINE 4% CREAM, DR. RICHS NUMBING, FIRSTCARE PAIN RELIEF GEL PATC ... Generic Name LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, ... Manufacturers VITRUVIAS THERAPEUTICS, Teligent Pharma, Inc., GenZ Online LLC, USpharma Ltd, Sa ... product_ndc 69680-120, 52565-122, 69191-500, 71594-601, 49873-617, 50488-2004, 63323-201, 24 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRoute TOPICAL, INFILTRATION, PERINEURAL, RECTAL, PERCUTANEOUS, TRANSDERMAL, EPIDURAL, ... Active Ingredients LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE, PHENYLEPHRINE HYDROCH ... RXCUI 1543069, 1421893, 1291672, 1737778, 1010033, 1366789, 1872886, 1534792, 1442274, ... spl_id 486396b5-d925-44a9-a3ad-530fc0b69ec0, a8eeed92-d89f-4119-b862-31e1f91f6b21, 47f5 ... spl_set_id a10d6d19-a275-483d-bf64-1ead5c30745c, a3216e25-82bb-4905-ac0b-b2ef4aa32ea0, a346 ... Package NDC 69680-120-35, 52565-122-07, 52565-122-15, 52565-122-30, 69191-500-06, 71594-601- ... NUIN0000175682, M0000897, N0000175426, N0000175976Established Pharmacologic ClassAmide Local Anesthetic [EPC], Antiarrhythmic [EPC]Chemical StructureAmides [CS]Physiologic/Pharmacodynamic EffectLocal Anesthesia [PE]UNII98PI200987, V13007Z41A, F5UM2KM3W7, 04JA59TNSJ, 30Q7KI53AK

39)

drugcharacterization2medicinalproductTRAMADOL HYDROCHLORIDE.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, UNK

activesubstance

activesubstancenameTRAMADOL HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090404, ANDA205257, NDA214044, ANDA076003, ANDA091498, NDA022370, ANDA208708 ... Brand Name TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE, QDOLO, ULTRAM, ... Generic NameTRAMADOL HYDROCHLORIDEManufacturers Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited, Mylan Pharmaceutica ... product_ndc 68382-319, 65841-754, 0378-4152, 0378-4153, 0378-4154, 68134-402, 65162-627, 695 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAMADOL HYDROCHLORIDERXCUI 835603, 833709, 833711, 833713, 2395808, 1148478, 1148485, 1148489, 2179635, 194 ... spl_id 1ddd72c1-be8f-4d56-9966-f9b5c45e98b9, f3ada848-9f0a-4197-aac5-ead4675f8095, fa56 ... spl_set_id ee7179b7-6a08-4eeb-a787-5d697b02c4a2, 6f3a2ab8-f437-456f-ae35-67a965396052, c88b ... Package NDC 68382-319-01, 68382-319-05, 68382-319-10, 68382-319-30, 68382-319-77, 65841-754- ... UNII9N7R477WCK

40)

drugcharacterization2medicinalproductZOLPIDEMdrugdosagetextUNK

activesubstance

activesubstancenameZOLPIDEM\ZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_ide4a5e984-a50b-4f1e-a50d-b1acd2b34d52spl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

41)

drugcharacterization2medicinalproductFOLIC ACID.drugdosagetextUNK

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Brand NameVENTRIXYL, FOLIC ACID, VENEXA, VITRAMYN, MULTITAM, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers PureTek Corporation, Leading Pharma, LLC, Amneal Pharmaceuticals of New York LLC ... product_ndc 59088-186, 69315-127, 53746-361, 10135-182, 59088-176, 71209-007, 11534-165, 586 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CALCIUM CARBONATE, CHOLECALCIFER ... spl_id c705632c-cd1a-0f43-e053-2995a90aa0b3, 92322e52-3179-4738-8c8a-14fef62311d4, ca64 ... spl_set_id c29dc729-93be-2a20-e053-2a95a90a8ca3, 1ba8c407-9613-4319-ac40-0a429cb0f3f4, fd85 ... Package NDC 59088-186-54, 69315-127-01, 69315-127-10, 53746-361-01, 53746-361-10, 10135-182- ... NUIN0000193618, M0001797, M0022797, N0000175952, M0022794, N0000175951Established Pharmacologic ClassVitamin C [EPC], Vitamin D [EPC], Vitamin B12 [EPC]Chemical StructureAscorbic Acid [CS], Vitamin D [CS], Vitamin B 12 [CS]UNII WR1WPI7EW8, PQ6CK8PD0R, H0G9379FGK, 1C6V77QF41, A150AY412V, P6YC3EG204, 935E97BO ... Application Number ANDA040796, ANDA040625, ANDA204418, ANDA202437, ANDA211064, ANDA202522, ANDA0911 ... RXCUI310410, 237786

42)

drugcharacterization2medicinalproductMICROGESTIN FEdrugdosagetextUNK

activesubstance

activesubstancenameETHINYL ESTRADIOL\FERROUS FUMARATE\NORETHINDRONE ACETATE

43)

drugcharacterization2medicinalproductMUPIROCIN.drugdosagetextUNKdrugdosageformOINTMENT

activesubstance

activesubstancenameMUPIROCIN

openFDA Info on Medication

Application Number ANDA213053, NDA050788, ANDA213076, ANDA065192, ANDA207116, ANDA201587, ANDA06508 ... Brand NameMUPIROCIN, CENTANY AT, CENTANY, PIRNUOGeneric NameMUPIROCIN, MUPIROCIN CALCIUMManufacturers Alembic Pharmaceuticals, Inc., Aleor Dermaceuticals Limited, Medimetriks Pharmac ... product_ndc 62332-624, 71589-015, 43538-310, 43538-300, 21922-029, 0168-0352, 16714-055, 684 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsMUPIROCIN CALCIUM, MUPIROCINRXCUI311877, 106346, 404070, 2286614spl_id fa444224-a0df-47cc-a925-a53dcdc26dc5, 4182dbe3-d821-4708-89a0-1f85ff0d4a0f, db7e ... spl_set_id a69cd608-d2e6-4a7a-8cd7-f761bd333542, ba6f4d05-2392-4484-b857-c1bf5015c713, 3240 ... Package NDC 62332-624-15, 62332-624-30, 71589-015-15, 71589-015-30, 43538-310-30, 43538-300- ... UNIIRG38I2P540, D0GX863OA5NUIN0000175515, N0000175516Established Pharmacologic ClassRNA Synthetase Inhibitor Antibacterial [EPC]Mechanism of ActionRNA Synthetase Inhibitors [MoA]

summary

narrativeincludeclinicalCASE EVENT DATE: 201409