Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10060864serious1Date Last Updated30/09/2014receiptdateformat102companynumbUS-ABBVIE-14P-163-1218431-00occurcountryUSseriousnessother1duplicate1Date Received04/04/2014transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification5

Patient

Onset Age76Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionCognitive disorderOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.1ReactionConvulsionOutcomeRecovered/resolved

3)

reactionmeddraversionpt17.1ReactionDrug ineffectiveOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt17.1ReactionAbasiaOutcomeRecovered/resolved

5)

reactionmeddraversionpt17.1ReactionDrug intoleranceOutcomeRecovered/resolved

6)

reactionmeddraversionpt17.1ReactionFatigueOutcomeRecovered/resolved

7)

reactionmeddraversionpt17.1ReactionDrug effect delayedOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt17.1ReactionPainOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt17.1ReactionFatigueOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt17.1ReactionDysarthriaOutcomeRecovered/resolved

11)

reactionmeddraversionpt17.1ReactionDyspnoeaOutcomeNot recovered/not resolved

12)

reactionmeddraversionpt17.1ReactionFeeling abnormalOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt17.1ReactionMalaiseOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt17.1ReactionSomnolenceOutcomeNot recovered/not resolved

15)

reactionmeddraversionpt17.1ReactionChillsOutcomeNot recovered/not resolved

16)

reactionmeddraversionpt17.1ReactionMotor dysfunctionOutcomeRecovered/resolved

17)

reactionmeddraversionpt17.1ReactionHypotensionOutcomeNot recovered/not resolved

18)

reactionmeddraversionpt17.1ReactionPyrexiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductPOTASSIUMdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePOTASSIUM

2)

drugcharacterization2medicinalproductTORSEMIDE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationHYPERTENSION

activesubstance

activesubstancenameTORSEMIDE

openFDA Info on Medication

Application NumberANDA090656, ANDA076346, ANDA078249, ANDA076943, ANDA079234Brand NameTORSEMIDEGeneric NameTORSEMIDEManufacturers American Regent, Inc., Teva Pharmaceuticals USA, Inc., Rising Health, LLC, West- ... product_ndc 0517-0770, 0517-0771, 50111-915, 50111-916, 50111-917, 50111-918, 57237-138, 572 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsTORSEMIDERXCUI1729521, 1729527, 198369, 198370, 198371, 198372spl_id d81b99eb-cb6d-4644-941e-12e671910a29, 64579b9f-9ba1-4832-9f06-47c925629740, 57cb ... spl_set_id ea443790-f0d1-47e3-b753-a118f67f9cfe, 8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9, 3c8f ... Package NDC 0517-0771-01, 0517-0771-10, 0517-0770-01, 0517-0770-10, 50111-915-01, 50111-916- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNIIW31X2H97FB

3)

drugcharacterization2medicinalproductSERTRALINEdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationDEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

4)

drugcharacterization2medicinalproductMORPHINEdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextER TABLETSdrugindicationPAIN

activesubstance

activesubstancenameMORPHINE

openFDA Info on Medication

Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

5)

drugcharacterization2medicinalproductVITAMIN Ddrugstructuredosagenumb2000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

6)

drugcharacterization2medicinalproductSULFASALAZINE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext6 PILLSdrugdosageformTABLETdrugindicationRHEUMATOID ARTHRITIS

activesubstance

activesubstancenameSULFASALAZINE

openFDA Info on Medication

Application NumberNDA007073, ANDA085828Brand NameAZULFIDINE EN-TABS, SULFASALAZINE, AZULFIDINEGeneric NameSULFASALAZINEManufacturersPharmacia & Upjohn Company LLC, Actavis Pharma, Inc., Greenstone LLCproduct_ndc0013-0102, 0591-0796, 59762-5000, 59762-0104, 0013-0101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSULFASALAZINERXCUI313142, 724154, 198232, 208437spl_id 0802bf55-2d66-4211-8974-2884c70011b2, 20023316-af84-4403-a277-13a9073c52e4, fe8b ... spl_set_id b9ef541a-93c8-4428-ba45-398aa0b327d1, ad13d598-7b1b-48d3-a25b-08635b419f99, 48fb ... Package NDC 0013-0102-01, 0013-0102-20, 0013-0102-50, 0013-0102-60, 0591-0796-01, 0591-0796- ... NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII3XC8GUZ6CB

7)

drugcharacterization2medicinalproductHYDROXYCHLOROQUINEdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameHYDROXYCHLOROQUINE

8)

drugcharacterization2medicinalproductFOLIC ACID.drugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationRHEUMATOID ARTHRITIS

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

9)

drugcharacterization2medicinalproductIRONdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

10)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb3drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

11)

drugcharacterization2medicinalproductHYDROCODONEdrugdosagetext10/325 MG, USUALLY TWICE DAILYdrugindicationPAIN

activesubstance

activesubstancenameHYDROCODONE

12)

drugcharacterization2medicinalproductBIOLOGICdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

13)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1011075drugauthorizationnumb125057drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosageformSolution for injection in pre-filled pendrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat610drugstartdate/02/2014drugenddateformat610drugenddate/04/2014actiondrug4

activesubstance

activesubstancenameADALIMUMAB

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id7a967019-f452-7b99-ba3d-e9b3ac703363spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

14)

drugcharacterization2medicinalproductWARFARINdrugdosagetextMON, WED, FRID AND SUNdrugdosageformTABLETdrugindicationARRHYTHMIA

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, f0ce7015-9133-4b90-a624-77fb776fbfa7spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

15)

drugcharacterization2medicinalproductMETHOTREXATEdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetextON WEDdrugindicationRHEUMATOID ARTHRITIS

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]

16)

drugcharacterization2medicinalproductLISINOPRIL.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationHYPERTENSIONdrugenddateformat102drugenddate07/03/2014

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

17)

drugcharacterization2medicinalproductSIMVASTATIN.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugindicationBLOOD TRIGLYCERIDES INCREASED

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)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationGASTROOESOPHAGEAL REFLUX DISEASE

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

19)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb7drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationRHEUMATOID ARTHRITIS

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

20)

drugcharacterization2medicinalproductACEBUTOLOLdrugdosageformTABLETdrugindicationARRHYTHMIA

activesubstance

activesubstancenameACEBUTOLOL

summary

narrativeincludeclinicalCASE EVENT DATE: 201404

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-14P-163-1218431-00

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use