Adverse Event Report

Report

reporttype1Version of Safety Report ID12receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10160700serious1Date Last Updated28/10/2016receiptdateformat102companynumbUS-ASTELLAS-2014US004967occurcountryUSseriousnessother1duplicate1Date Received08/05/2014seriousnesshospitalization1transmissiondate06/02/2017primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age82Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionGastrooesophageal reflux diseaseOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.1ReactionOnychoclasisOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionRashOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt19.1ReactionAcneOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.1ReactionMyasthenia gravisOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt19.1ReactionRashOutcomeUnknown

7)

reactionmeddraversionpt19.1ReactionNail bed bleedingOutcomeUnknown

8)

reactionmeddraversionpt19.1ReactionRhinorrhoeaOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionOnychalgiaOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt19.1ReactionFatigueOutcomeUnknown

11)

reactionmeddraversionpt19.1ReactionHeadacheOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt19.1ReactionInfectionOutcomeUnknown

13)

reactionmeddraversionpt19.1ReactionLip dryOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt19.1ReactionIntervertebral disc degenerationOutcomeUnknown

15)

reactionmeddraversionpt19.1ReactionPain in extremityOutcomeUnknown

16)

reactionmeddraversionpt19.1ReactionEyelids pruritusOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt19.1ReactionPeripheral swellingOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt19.1ReactionIngrowing nailOutcomeUnknown

19)

reactionmeddraversionpt19.1ReactionNail disorderOutcomeUnknown

20)

reactionmeddraversionpt19.1ReactionPainOutcomeUnknown

21)

reactionmeddraversionpt19.1ReactionVision blurredOutcomeUnknown

22)

reactionmeddraversionpt19.1ReactionNail bed inflammationOutcomeUnknown

23)

reactionmeddraversionpt19.1ReactionAtrial fibrillationOutcomeUnknown

24)

reactionmeddraversionpt19.1ReactionNail ridgingOutcomeNot recovered/not resolved

25)

reactionmeddraversionpt19.1ReactionRash erythematousOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MG, DAILYdrugdosageformTABLETdrugadministrationroute048drugindicationLUNG NEOPLASM MALIGNANTdrugstartdateformat102drugstartdate18/01/2014actiondrug4

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

2)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate25/07/2015drugenddateformat102drugenddate31/08/2015actiondrug6

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

3)

drugcharacterization2medicinalproductPEPCIDdrugstructuredosagenumb20drugstructuredosageunit003drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameFAMOTIDINE

openFDA Info on Medication

Application NumberNDA019527, ANDA075805Brand NamePEPCIDGeneric NameFAMOTIDINEManufacturersSalix Pharmaceuticals, Inc, Bausch Health Americas Inc.product_ndc65649-211, 0187-4420, 0187-4440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFAMOTIDINERXCUI206873, 310274, 104094, 104095, 284245, 310273spl_id9e8f6a6d-4f04-4201-8d8e-802f08125adc, 117ab388-f0c2-4d9b-9cd0-1b7c478a665cspl_set_id4f1a0b58-f7c8-485e-a317-432e1c374d2f, a06502d9-7903-4f37-833e-e5763d502defPackage NDC65649-211-24, 0187-4420-30, 0187-4420-10, 0187-4440-30, 0187-4440-10NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

4)

drugcharacterization2medicinalproductSIMPONIdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameGOLIMUMAB

openFDA Info on Medication

Application NumberBLA125289Brand NameSIMPONIGeneric NameGOLIMUMABManufacturersJanssen Biotech, Inc.product_ndc57894-070, 57894-071Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsGOLIMUMABRXCUI848160, 848164, 1482813, 1482814, 1653142, 1653144, 1653165, 1653166spl_id19ce6e44-67ea-11e9-a359-5dd70099106dspl_set_idf86cb4a7-c358-4136-ae57-b32bda9bba00Package NDC 57894-070-01, 57894-070-02, 57894-070-90, 57894-070-89, 57894-071-01, 57894-071- ... NUIN0000175610, N0000175451Established Pharmacologic ClassTumor Necrosis Factor Blocker [EPC]Mechanism of ActionTumor Necrosis Factor Receptor Blocking Activity [MoA]UNII91X1KLU43E

5)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate30/08/2013actiondrug6

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

6)

drugcharacterization2medicinalproductGUANFACINE HCLdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameGUANFACINE HYDROCHLORIDE

7)

drugcharacterization2medicinalproductMETHOTREXATE.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA040632, ANDA201529, ANDA201530, NDA008085 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Hikma Pharmac ... product_ndc 61703-350, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 0143-9830, 674 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS, ORAL, INTRATHECAL, SUBCUTANEOUSActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625, ... spl_id 60bbb387-0ce5-4c7e-a917-5bc4b4685616, 78d0abc0-9ade-4302-ada0-72fd6d67eff9, 46c4 ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-350-09, 61703-350-10, 51285-366-01, 51285-367- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

8)

drugcharacterization2medicinalproductATORVASTATINdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

9)

drugcharacterization2medicinalproductNIASPANdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameNIACIN

openFDA Info on Medication

Application NumberNDA020381Brand NameNIASPANGeneric NameNIACINManufacturersAbbVie Inc.product_ndc0074-3265, 0074-3074, 0074-3079, 0074-3080, 0074-3274, 0074-3275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNIACINRXCUI1098134, 1098135, 1098141, 1098142, 1098143, 1098144spl_id4996cc96-b2b9-7f7a-41e9-e3cd5e43c298spl_set_id35433c7b-556c-49a0-bfb5-0d498359925bPackage NDC 0074-3074-90, 0074-3074-03, 0074-3074-07, 0074-3074-30, 0074-3079-90, 0074-3079- ... NUIN0000175594, M0014839Established Pharmacologic ClassNicotinic Acid [EPC]Chemical StructureNicotinic Acids [CS]UNII2679MF687A

10)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate08/08/2013actiondrug6

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

11)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate22/10/2013actiondrug6

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

12)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

13)

drugcharacterization2medicinalproductADVAIR HFAdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

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_id499c58ac-7a9c-488d-ab84-74e90b8b7dc7spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

14)

drugcharacterization2medicinalproductLOSARTAN.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameLOSARTAN

15)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate17/10/2015actiondrug5drugadditional3

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

16)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

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

17)

drugcharacterization2medicinalproductSIMVASTATIN.drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, 1 IN 1 DAYdrugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameSIMVASTATIN

openFDA Info on Medication

Application Number NDA206679, ANDA078155, ANDA077691, ANDA078103, ANDA090383, ANDA078034, ANDA07783 ... Brand NameFLOLIPID, SIMVASTATIN, ZOCORGeneric NameSIMVASTATINManufacturers Salerno Pharmaceuticals Co., Accord Healthcare, Inc., NorthStar Rx LLC, Lupin Ph ... product_ndc 29273-401, 29273-402, 16729-004, 16729-156, 16729-005, 16729-006, 16729-007, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSIMVASTATINRXCUI 1790679, 1944262, 1944264, 1944266, 198211, 200345, 312961, 312962, 314231, 1044 ... spl_id 37ec6157-4088-4638-8eba-74a6aa1238d3, a467e8e1-fe36-61f4-e053-2a95a90a3c3c, 81d3 ... spl_set_id 6ee17d10-6eb1-452a-99e8-02381368b3fe, 871251c0-36a1-4a32-9eab-ff6c1e925ca9, 0376 ... Package NDC 29273-401-04, 29273-402-04, 16729-156-10, 16729-156-15, 16729-156-17, 16729-004- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNIIAGG2FN16EV

18)

drugcharacterization2medicinalproductGABAPENTIN.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

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, 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

19)

drugcharacterization2medicinalproductGEMFIBROZIL.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameGEMFIBROZIL

openFDA Info on Medication

Application Number ANDA203266, NDA018422, ANDA204189, ANDA079072, ANDA077836, ANDA214603, ANDA20272 ... Brand NameGEMFIBROZIL, LOPIDGeneric NameGEMFIBROZILManufacturers Cadila Pharmaceuticals Limited, Parke-Davis Div of Pfizer Inc, Cadila Healthcare ... product_ndc 71209-008, 0071-0737, 70771-1431, 16714-101, 76282-225, 75834-131, 31722-128, 43 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGEMFIBROZILRXCUI310459, 205751spl_id ab179aa0-e982-4685-bd47-47b85bbdedf1, ef2b3c7e-b287-4cae-9bc3-86fb6ccbe9ae, d1d0 ... spl_set_id 0b50849a-66b6-4e8f-9f45-5425a875d366, c48855b7-215e-453b-b3b1-a0f9dee7221f, e6bc ... Package NDC 71209-008-03, 71209-008-08, 71209-008-10, 0071-0737-20, 0071-0737-30, 70771-1431 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIQ8X02027X3

20)

drugcharacterization2medicinalproductNYSTATIN.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameNYSTATIN

openFDA Info on Medication

Application Number ANDA203621, ANDA064142, ANDA211838, ANDA062124, ANDA062838, ANDA065148, ANDA0651 ... Brand NameNYSTATIN, NYAMYC, NYSTOPGeneric NameNYSTATIN, NYSTATIN ORAL SUSPENSION, NYSTATIN OINTMENT, NYSTATIN CREAMManufacturers Pharmaceutical Associates, Inc., VistaPharm, Inc., Torrent Pharmaceuticals Limit ... product_ndc 0121-0810, 0121-4810, 66689-037, 13668-534, 0168-0007, 53489-400, 80432-003, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, TOPICALActive IngredientsNYSTATINRXCUI312055, 884308, 312059, 584414, 646456, 543546, 261178spl_id a9034435-e353-7bf6-e053-2995a90a4867, 91e9fe62-a1e7-46e6-8357-cdc2a93cc62f, bede ... spl_set_id 31e3da10-5a7b-4bc5-8a4f-3e786b64c13a, 41034d7b-33a1-4d6d-b425-9cfefff8d518, 4949 ... Package NDC 0121-0810-02, 0121-0810-16, 0121-4810-05, 0121-4810-40, 0121-4810-00, 0121-4810- ... NUIN0000175498, M0017172Established Pharmacologic ClassPolyene Antifungal [EPC]Chemical StructurePolyenes [CS]UNIIBDF1O1C72E

21)

drugcharacterization2medicinalproductDOXYCYCLINE.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameDOXYCYCLINE

openFDA Info on Medication

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

22)

drugcharacterization2medicinalproductMETOPROLOL.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameMETOPROLOL

openFDA Info on Medication

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

23)

drugcharacterization1medicinalproductTARCEVAdrugauthorizationnumb021743drugstructuredosagenumb100drugstructuredosageunit003drugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate07/09/2015actiondrug6

activesubstance

activesubstancenameERLOTINIB HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021743Brand NameTARCEVAGeneric NameERLOTINIB HYDROCHLORIDEManufacturersGenentech, Inc.product_ndc50242-062, 50242-063, 50242-064Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERLOTINIB HYDROCHLORIDERXCUI603203, 603206, 603208, 1088251, 1088253, 1088255spl_id5c1bf1f1-3ef7-4411-9305-b4f4080b769aspl_set_id57bccb29-1c47-4c64-ab6a-77960a91cc20Package NDC50242-062-01, 50242-063-01, 50242-064-01UNIIDA87705X9K

24)

drugcharacterization2medicinalproductATIVANdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

25)

drugcharacterization2medicinalproductOMEPRAZOLE.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

26)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb5drugstructuredosageunit003drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

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

27)

drugcharacterization2medicinalproductLEVAQUINdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameLEVOFLOXACIN

openFDA Info on Medication

28)

drugcharacterization2medicinalproductASPIRIN.drugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

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

29)

drugcharacterization2medicinalproductTHYROIDdrugdosagetextUNK UNK, UNKNOWN FREQ.drugdosageformFORMULATION UNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug6drugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE\LIOTHYRONINE

openFDA Info on Medication

Brand NameTHYROID, THYROIDINUMGeneric Name CALCAREA IODATA, FERRUM IODATUM, KALI IODATUM, SPONGIA TOSTA, FUCUS VESICULOSUS, ... ManufacturersProBlen, Seroyal USA, White Manufacturing Inc. DBA Micro-Westproduct_ndc43853-0024, 62106-7140, 61657-0952Product TypeHUMAN OTC DRUGRouteORALActive Ingredients FERROUS IODIDE, POTASSIUM IODIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, FUCUS V ... spl_id e159d2ac-7f87-422b-8b3a-9dd2c8e01d8e, 9a074048-5cf3-80a5-e053-2995a90a5e2f, b970 ... spl_set_id d2767723-a0a1-4b63-94ad-eee4ca288d4f, 120ae248-4bb3-6892-e054-00144ff88e88, 5b02 ... Package NDC43853-0024-1, 62106-7140-4, 61657-0952-1UNII F5452U54PN, 1C4QK22F9J, 1PIP394IID, 535G2ABX9M, 0B4FDL9I6P, 398IYQ16YV, L0PFEMQ1 ...

summary

narrativeincludeclinicalCASE EVENT DATE: 201401

Report Duplicate

duplicatesourceASTELLASduplicatenumbUS-ASTELLAS-2014US004967

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use