Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10159836serious1Date Last Updated08/05/2014receiptdateformat102companynumbUS-BAYER-2014-062866occurcountryUSseriousnessother1duplicate1Date Received08/05/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age62Unit of Onset AgeyearsWeight71.2SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAtrial fibrillationOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionHeart rate decreasedOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.0ReactionSurgeryOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionVentricular extrasystolesOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionHypotensionOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.0ReactionChest painOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionBlood pressure increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSOTALOLdrugauthorizationnumb019865drugdosagetextUNKdrugdosageformTABLETdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat602drugstartdate//2012drugenddateformat610drugenddate/01/2014

openFDA Info on Medication

Application NumberANDA207428Brand NameSOTALOLGeneric NameSOTALOL HYDROCHLORIDEManufacturersBayshore Pharmaceuticals LLCproduct_ndc76385-114, 76385-115, 76385-116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOTALOL HYDROCHLORIDERXCUI1923422, 1923424, 1923426spl_id6d091d32-9a0e-45ad-a9a1-35dc92dbe8a0spl_set_id56879738-8662-4f5c-8386-761ab2b5e46fPackage NDC 76385-114-01, 76385-114-50, 76385-115-01, 76385-115-50, 76385-116-01, 76385-116- ... UNIIHEC37C70XX

2)

drugcharacterization1medicinalproductSOTALOLdrugauthorizationnumb019865drugdosageformTABLETdrugindicationVENTRICULAR EXTRASYSTOLES

openFDA Info on Medication

Application NumberANDA207428Brand NameSOTALOLGeneric NameSOTALOL HYDROCHLORIDEManufacturersBayshore Pharmaceuticals LLCproduct_ndc76385-114, 76385-115, 76385-116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSOTALOL HYDROCHLORIDERXCUI1923422, 1923424, 1923426spl_id6d091d32-9a0e-45ad-a9a1-35dc92dbe8a0spl_set_id56879738-8662-4f5c-8386-761ab2b5e46fPackage NDC 76385-114-01, 76385-114-50, 76385-115-01, 76385-115-50, 76385-116-01, 76385-116- ... UNIIHEC37C70XX

3)

drugcharacterization1medicinalproductAMPYRAdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, BIDdrugadministrationroute048drugindicationGAIT DISTURBANCE

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Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_id99d8ffc6-164d-b055-e053-2995a90ad0c9spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

4)

drugcharacterization1medicinalproductLOPRESSORdrugdosagetextUNKdrugadministrationroute048drugindicationATRIAL FIBRILLATIONdrugstartdateformat602drugstartdate//2004drugenddateformat602drugenddate//2012

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Application NumberNDA017963Brand NameLOPRESSORGeneric NameMETOPROLOL TARTRATEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-458, 30698-459Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL TARTRATERXCUI866511, 866513, 866514, 866516spl_id0ed7956e-dc30-4330-805e-80ff7f3d6012spl_set_id0283bc9d-6998-493a-824a-d4c85f704111Package NDC30698-458-01, 30698-459-01UNIIW5S57Y3A5L

5)

drugcharacterization2medicinalproductARICEPTdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, HS

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Application NumberNDA020690, NDA022568, NDA021720Brand NameARICEPT, ARICEPT ODTGeneric NameDONEPEZIL HYDROCHLORIDEManufacturersEisai Inc.product_ndc62856-245, 62856-246, 62856-247, 62856-831, 62856-832Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDONEPEZIL HYDROCHLORIDERXCUI997220, 997222, 997223, 997224, 997226, 997228, 997229, 997230, 1100184, 1100187spl_idc2ef5afe-3d12-4cb8-90e4-2ac294b610e8spl_set_id98e451e1-e4d7-4439-a675-c5457ba20975Package NDC 62856-245-41, 62856-245-11, 62856-245-30, 62856-245-90, 62856-246-41, 62856-246- ... UNII3O2T2PJ89D

6)

drugcharacterization2medicinalproductASPIRINdrugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext325 MG, QD

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Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

7)

drugcharacterization2medicinalproductBACLOFENdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, BID

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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)

drugcharacterization2medicinalproductBACLOFENdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MG, HS

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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)

drugcharacterization2medicinalproductDETROL LAdrugstructuredosagenumb4drugstructuredosageunit003drugdosagetext4 MG, 1-2 TIMES DAILY

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Application NumberNDA021228Brand NameDETROL LAGeneric NameTOLTERODINE TARTRATEManufacturersPharmacia and Upjohn Company LLCproduct_ndc0009-5190, 0009-5191Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOLTERODINE TARTRATERXCUI855182, 855184, 855189, 855191spl_id54731895-ffd4-4d24-acb1-97fdde96382fspl_set_idc98eb213-9c80-4698-9710-a9855059b8bbPackage NDC 0009-5190-01, 0009-5190-02, 0009-5190-03, 0009-5190-04, 0009-5191-01, 0009-5191- ... UNII5T619TQR3R

10)

drugcharacterization2medicinalproductSYNTHROIDdrugstructuredosagenumb.125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.125 MG, QD

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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_iddb21fc0c-4a2d-9922-39bd-8128e429bebcspl_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

11)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QD

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Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_id0ba214c6-250e-42a0-aea8-5e44aba04882spl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-10, 0071-0155-97, 0071-0156-23, 0071-0156- ... UNII48A5M73Z4Q

12)

drugcharacterization2medicinalproductNEURONTINdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600 MG, TID

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Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id597965f8-e2d2-4010-b57b-482f6e59a810spl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

13)

drugcharacterization2medicinalproductNEXIUMdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, BID BEFORE MEALS

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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

14)

drugcharacterization2medicinalproductNUVIGILdrugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext250 MG, QD

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Application NumberNDA021875Brand NameNUVIGILGeneric NameARMODAFINILManufacturersCephalon, Inc.product_ndc63459-205, 63459-215, 63459-220, 63459-225Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARMODAFINILRXCUI724859, 724861, 724863, 805659, 805661, 805663, 861960, 861962spl_id12eab811-a6da-495f-8ba1-0cb52ccc5914spl_set_idd878aed0-ddbf-8fa1-abf7-d3e480260845Package NDC 63459-205-30, 63459-215-07, 63459-215-35, 63459-215-30, 63459-220-07, 63459-220- ... UNIIV63XWA605I

15)

drugcharacterization2medicinalproductTYSABRIdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosagetext300/15 ML INJECTION, Q1MON

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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

16)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, BID

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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)

drugcharacterization2medicinalproductMULTIVITAMINSdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QD

18)

drugcharacterization2medicinalproductFISH OILdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, BID

openFDA Info on Medication

Application NumberNDA210589Brand NameOMEGAVENGeneric NameFISH OILManufacturersFresenius Kabi USA, LLCproduct_ndc63323-205Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsFISH OILRXCUI2053499, 2053504, 2053513, 2053514spl_idc4f460d5-da90-4b9b-aff1-df3176a43d47spl_set_id5d9d0b24-e139-48bf-ab2d-536fb59cf8e0Package NDC63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00UNIIXGF7L72M0F

19)

drugcharacterization2medicinalproductVITAMIN B6drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QD

20)

drugcharacterization2medicinalproductVITAMIN B12drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QD

21)

drugcharacterization2medicinalproductCALCIUM +VIT Ddrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QD

22)

drugcharacterization2medicinalproductBIOTINdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QD

openFDA Info on Medication

Brand NameHAIRJOY EYEBROW SIGNATURE, HAIRJOY EYELASH SIGNATUREGeneric NameBIOTINManufacturersHAIRJOYproduct_ndc69384-090, 69384-080Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsBIOTINspl_ide3180639-1e79-4ccd-be0d-119f17386386, 6159acee-5315-4e8f-b37b-88b4244c3cf8spl_set_ideb0813ab-dea6-4b13-b517-8e1ad1861c5d, ca42d0a4-b9f8-48b9-bd4c-8c669e31e772Package NDC69384-090-01, 69384-090-02, 69384-080-01, 69384-080-02UNII6SO6U10H04

23)

drugcharacterization2medicinalproductLYSINEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UNK, QD

24)

drugcharacterization2medicinalproductAMOXICILLINdrugdosagetextUNKdrugindicationPROPHYLAXIS

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Application Number ANDA064076, ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers DAVA Pharmaceuticals Inc, Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals U ... product_ndc 67253-144, 67253-150, 67253-146, 67253-147, 67253-148, 67253-149, 0143-9285, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI239191, 308182, 308189, 308191, 313797, 313850, 308194, 308192, 308177, 598025spl_id 0972267b-1a1b-40da-b95c-2dc7be21720e, 11f42795-cdea-4c98-a921-2c54e40370ba, 56ab ... spl_set_id 5f55a89f-a7ca-497f-a17c-f751431e2cfb, c8591c2a-92ef-4432-b19a-bb46063047ee, 20c8 ... Package NDC 67253-144-10, 67253-144-50, 67253-150-10, 67253-150-50, 67253-146-45, 67253-146- ... UNII804826J2HU

25)

drugcharacterization2medicinalproductINFLUENZA VACCINEdrugdosagetextANNUALLY

26)

drugcharacterization2medicinalproductNAPROSYNdrugstructuredosagenumb250drugstructuredosageunit003drugdosagetext250 MG, UNK

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Application NumberNDA018965, NDA017581Brand NameNAPROSYNGeneric NameNAPROXENManufacturersAthena Bioscience, Canton Laboratoriesproduct_ndc71511-701, 69437-316, 69437-415, 69437-416, 69437-203Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNAPROXENRXCUI207093, 311913, 105899, 198014, 311915, 603103, 608793, 835560, 849431, 849438spl_id2513454d-a89e-4bb4-ba9e-c344046bbafe, 0aa005eb-b5a2-4f9b-9fa8-0c543a7752b3spl_set_idf9b4173d-7836-4d7d-b149-1d96f9377ad0, 8bff5df5-d856-4237-b6a8-ae445b454844Package NDC71511-701-16, 69437-316-01, 69437-415-01, 69437-416-01, 69437-203-01NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNII57Y76R9ATQ, 9TN87S3A3C

27)

drugcharacterization2medicinalproductCOMBIVENT

28)

drugcharacterization2medicinalproductDOXYCYCLINEdrugstructuredosagenumb100drugstructuredosageunit003drugdosagetext100 MG, UNK

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Application Number ANDA201678, ANDA204234, ANDA209396, ANDA065053, ANDA062432, ANDA210664, ANDA0652 ... Brand Name DOXYCYCLINE, OKEBO, DOXYCYCLINE HYCLATE, ORACEA, VIBRAMYCIN MONOHYDRATE, DOXY 10 ... Generic NameDOXYCYCLINE, DOXYCYCLINE HYCLATEManufacturers Lupin Pharmaceuticals, Inc., Encore Dermatology Inc., Mayne Pharma Inc., Sun Pha ... product_ndc 68180-657, 69482-450, 68180-650, 68180-651, 68180-652, 51862-040, 51862-041, 518 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsDOXYCYCLINE, DOXYCYCLINE HYCLATERXCUI 1650030, 1649990, 2045900, 700408, 1649401, 1650143, 1649429, 1650142, 1650444, ... spl_id bf2b026c-0185-4fc1-a87e-f3f26c47a20f, 5d199431-f92b-4797-a8f6-070d3cd1b900, 1c7d ... spl_set_id e0e80435-1b6a-4361-8c8a-e432f8f23a1b, 5c9f1141-7eb5-5513-e053-2991aa0ad5b3, bcc6 ... Package NDC 68180-657-01, 69482-450-50, 69482-450-06, 68180-650-01, 68180-651-01, 68180-652- ... NUIN0000175882, N0000007948Established Pharmacologic ClassTetracycline-class Drug [EPC]Chemical StructureTetracyclines [Chemical/Ingredient]UNIIN12000U13O, 19XTS3T51U, 8ZL07I20SB

29)

drugcharacterization2medicinalproductFLONASEdrugstructuredosagenumb.05drugstructuredosageunit030drugdosagetext0.05 %, UNK

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Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

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duplicatesourceBAYERduplicatenumbUS-BAYER-2014-062866

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receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use