Adverse Event Report

Report

reporttype1Version of Safety Report ID7receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10068279serious1Date Last Updated24/03/2015receiptdateformat102companynumbUS-PFIZER INC-2014096636occurcountryUSseriousnessother1duplicate1Date Received09/04/2014seriousnesshospitalization1transmissiondate20/07/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age64Unit of Onset AgeyearsWeight106SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionAstheniaOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionSkin discolourationOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionMalaiseOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionBacteraemiaOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionArthropod biteOutcomeUnknown

6)

reactionmeddraversionpt18.0ReactionExpired product administeredOutcomeUnknown

7)

reactionmeddraversionpt18.0ReactionPneumoniaOutcomeUnknown

8)

reactionmeddraversionpt18.0ReactionUrinary tract infectionOutcomeUnknown

9)

reactionmeddraversionpt18.0ReactionWeight decreasedOutcomeUnknown

10)

reactionmeddraversionpt18.0ReactionHearing impairedOutcomeUnknown

11)

reactionmeddraversionpt18.0ReactionPeripheral swellingOutcomeUnknown

12)

reactionmeddraversionpt18.0ReactionOxygen saturation decreasedOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, 3X/DAYdrugindicationPANIC DISORDER

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

2)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, 2X/DAYdrugindicationDIABETES MELLITUS

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, a353 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

3)

drugcharacterization2medicinalproductANDROGELdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK, 1X/DAY

activesubstance

activesubstancenameTESTOSTERONE

openFDA Info on Medication

Application NumberNDA022309, NDA021015Brand NameANDROGELGeneric NameTESTOSTERONEManufacturersAbbVie Inc.product_ndc0051-8462, 0051-8425, 0051-8488, 0051-8450Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsTESTOSTERONERXCUI 1597075, 1597076, 1597120, 1597121, 1597126, 1597127, 1596780, 1597074, 1597123, ... spl_id82f7abad-fc55-fb9a-dd1a-a7078ed950b1, 98c4655b-0eb4-e920-a954-2143fda23603spl_set_id8677ba5b-8374-46cb-854c-403972e9ddf3, c506aaa3-04f8-4eb1-8dc4-e964cdd08e7fPackage NDC 0051-8462-33, 0051-8462-12, 0051-8462-31, 0051-8462-01, 0051-8462-30, 0051-8488- ... NUIN0000175824, N0000000146, M0001109Established Pharmacologic ClassAndrogen [EPC]Mechanism of ActionAndrogen Receptor Agonists [MoA]Chemical StructureAndrostanes [CS]UNII3XMK78S47O

4)

drugcharacterization2medicinalproductADVAIR DISKUSdrugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500MG/50 MG, 2X/DAY

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

5)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetext30 MG IN THE MORNING AND 100 MG IN THE NIGHT

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

6)

drugcharacterization1medicinalproductREVATIOdrugbatchnumbA3A23901drugauthorizationnumb021845drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, 3X/DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048actiondrug4

activesubstance

activesubstancenameSILDENAFIL CITRATE

openFDA Info on Medication

Application NumberNDA203109, NDA022473, NDA021845Brand NameREVATIOGeneric NameSILDENAFIL CITRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-0336, 0069-4190, 0069-0338Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsSILDENAFIL CITRATERXCUI577033, 581645, 882527, 882530, 1307427, 1307431spl_ideeeb2d77-bc88-45e8-afb2-f18cc8aa941espl_set_idf158fe10-d5dc-4432-b2c9-fc665401291bPackage NDC0069-4190-68, 0069-0338-01, 0069-0336-21UNIIBW9B0ZE037

7)

drugcharacterization2medicinalproductGLIMEPIRIDE.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 1X/DAYdrugindicationDIABETES MELLITUS

activesubstance

activesubstancenameGLIMEPIRIDE

openFDA Info on Medication

Application Number ANDA077911, ANDA077091, ANDA091220, ANDA078181, NDA020496, ANDA077370, ANDA20275 ... Brand NameGLIMEPIRIDE, AMARYLGeneric NameGLIMEPIRIDEManufacturers Carlsbad Technology, Inc., Dr. Reddy's Laboratories Limited, Micro Labs Limited, ... product_ndc 61442-115, 61442-116, 61442-117, 55111-320, 55111-321, 55111-322, 42571-100, 425 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGLIMEPIRIDERXCUI199245, 199246, 199247, 153842, 1361493, 1361495, 153591, 153843, 153845spl_id 94f7e51b-3f92-8633-e053-2995a90a8cf1, e3d50334-9896-b2f9-a481-8383eb84b16a, ab8d ... spl_set_id 72d88c6d-2f0a-4bf8-aa7f-1e1811794187, 07ad4366-4b21-f633-49f3-c2b35f88168d, 60e9 ... Package NDC 61442-115-01, 61442-115-05, 61442-115-10, 61442-116-01, 61442-116-05, 61442-116- ... NUIN0000175608, M0020795Established Pharmacologic ClassSulfonylurea [EPC]Chemical StructureSulfonylurea Compounds [CS]UNII6KY687524K

8)

drugcharacterization2medicinalproductLORATADINE.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNK

activesubstance

activesubstancenameLORATADINE

openFDA Info on Medication

Application Number ANDA210722, ANDA076471, ANDA076301, ANDA202538, ANDA076805, ANDA075209, ANDA0757 ... Brand Name LORATADINE, ALLERGY RELIEF, CHILDRENS LORATADINE SUGAR FREE, COUNTERACT ALLERGY, ... Generic NameLORATADINE, LORATADINE ORALManufacturers Granules India Ltd, Geri-Care Pharmaceutical Corp, Shopko Stores Operating Co., ... product_ndc 62207-787, 57896-788, 37012-612, 69452-211, 69842-540, 54473-166, 36800-608, 036 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINE, FAMOTIDINERXCUI 311372, 828269, 692783, 1087051, 311373, 665078, 744830, 206805, 1020126, 755478 ... spl_id 9aadc2f2-d0ea-5297-e053-2995a90ac51e, 9aa07ca9-ee19-89c7-e053-2a95a90ae9b5, 105d ... spl_set_id 0dee9036-d51f-4d7f-b5e2-4f6940249eef, 41fab408-35cb-47cc-bd4e-bba4ec10f6c7, 47b0 ... Package NDC 62207-787-51, 62207-787-59, 57896-788-03, 57896-788-09, 37012-612-65, 37012-612- ... UNII7AJO3BO7QN, 5QZO15J2Z8NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

9)

drugcharacterization1medicinalproductREVATIOdrugauthorizationnumb021845drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, 3X/DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationPULMONARY HYPERTENSIONdrugstartdateformat602drugstartdate//2005actiondrug4

activesubstance

activesubstancenameSILDENAFIL CITRATE

openFDA Info on Medication

Application NumberNDA203109, NDA022473, NDA021845Brand NameREVATIOGeneric NameSILDENAFIL CITRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-0336, 0069-4190, 0069-0338Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsSILDENAFIL CITRATERXCUI577033, 581645, 882527, 882530, 1307427, 1307431spl_ideeeb2d77-bc88-45e8-afb2-f18cc8aa941espl_set_idf158fe10-d5dc-4432-b2c9-fc665401291bPackage NDC0069-4190-68, 0069-0338-01, 0069-0336-21UNIIBW9B0ZE037

10)

drugcharacterization1medicinalproductREVATIOdrugauthorizationnumb021845drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 3X/DAYdrugdosageformFILM-COATED TABLETdrugadministrationroute048actiondrug4

activesubstance

activesubstancenameSILDENAFIL CITRATE

openFDA Info on Medication

Application NumberNDA203109, NDA022473, NDA021845Brand NameREVATIOGeneric NameSILDENAFIL CITRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-0336, 0069-4190, 0069-0338Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsSILDENAFIL CITRATERXCUI577033, 581645, 882527, 882530, 1307427, 1307431spl_ideeeb2d77-bc88-45e8-afb2-f18cc8aa941espl_set_idf158fe10-d5dc-4432-b2c9-fc665401291bPackage NDC0069-4190-68, 0069-0338-01, 0069-0336-21UNIIBW9B0ZE037

11)

drugcharacterization2medicinalproductDESONIDE.drugdosagetextUNKdrugdosageformCREAM

activesubstance

activesubstancenameDESONIDE

openFDA Info on Medication

Application Number ANDA212002, ANDA202161, NDA017010, ANDA210198, ANDA209729, ANDA208836, ANDA20785 ... Brand NameDESONIDE, DESONATE, VERDESO, DESOWENGeneric NameDESONIDEManufacturers Teligent Pharma, Inc., Taro Pharmaceuticals U.S.A., Inc., Perrigo New York Inc, ... product_ndc 52565-038, 51672-4079, 45802-422, 70771-1381, 68462-252, 61748-470, 0115-1517, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsDESONIDERXCUI204135, 197572, 349351, 669081, 692757, 668350, 669750, 205529, 205534spl_id 0b2d209c-8b07-4ff6-9180-49f0e83b4443, d2a454ff-03d9-4bd5-a563-c502fa3cf1a0, 1e79 ... spl_set_id 6b2b161f-8ddf-4b16-973f-b32059f9c4d1, af607c32-3da9-4fbe-99e7-4934a5c8d8f0, 8db1 ... Package NDC 52565-038-15, 52565-038-60, 51672-4079-4, 51672-4079-8, 45802-422-35, 45802-422- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIJ280872D1O

12)

drugcharacterization2medicinalproductLISINOPRIL.drugdosagetextUNKdrugindicationBLOOD PRESSURE ABNORMAL

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

13)

drugcharacterization2medicinalproductLETAIRISdrugbatchnumbNZXXdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 1X/DAYdrugindicationPULMONARY HYPERTENSIONdrugstartdateformat610drugstartdate/02/2013

activesubstance

activesubstancenameAMBRISENTAN

openFDA Info on Medication

Application NumberNDA022081Brand NameLETAIRISGeneric NameAMBRISENTANManufacturersGilead Sciences, Incproduct_ndc61958-0801, 61958-0802Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMBRISENTANRXCUI722116, 722120, 722122, 722124spl_idb6b19f3a-0619-cb36-e053-2995a90a5254spl_set_id725d4e73-6c83-477a-adc6-0ae4a133a844Package NDC 61958-0801-2, 61958-0801-3, 61958-0801-1, 61958-0801-5, 61958-0801-4, 61958-0801 ... NUIN0000175581, N0000175364Established Pharmacologic ClassEndothelin Receptor Antagonist [EPC]Mechanism of ActionEndothelin Receptor Antagonists [MoA]UNIIHW6NV07QEC

14)

drugcharacterization2medicinalproductZOLOFTdrugdosagetextUNKdrugindicationPANIC DISORDER

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

15)

drugcharacterization2medicinalproductFLUOCINONIDE.drugdosagetextUNKdrugadministrationroute061

activesubstance

activesubstancenameFLUOCINONIDE

openFDA Info on Medication

Application Number NDA019117, ANDA072494, ANDA075008, ANDA074935, ANDA206003, ANDA207680, ANDA20911 ... Brand NameFLUOCINONIDE, VANOS, FLUOCINONIDE CREAM, FLUOCINOL PAKGeneric NameFLUOCINONIDE, FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%Manufacturers Taro Pharmaceuticals U.S.A., Inc., Novel Laboratories, Inc., Teligent Pharma, In ... product_ndc 51672-1253, 51672-1254, 51672-1279, 51672-1264, 40032-026, 52565-040, 71428-001, ... Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsFLUOCINONIDERXCUI103456, 103457, 310362, 1801283, 310364, 485647, 543484spl_id 2b0274c4-7f1e-479c-a172-f1bd22c22797, 09d4aa56-fa9a-4697-aeab-87ba2f0cca92, 7376 ... spl_set_id b0bc89a9-c9d5-4adb-9785-2d4487c4c656, f820f497-9ad9-482d-ac92-46a7afa58968, 222e ... Package NDC 51672-1253-1, 51672-1253-2, 51672-1253-3, 51672-1253-4, 51672-1254-1, 51672-1254 ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII2W4A77YPAN

16)

drugcharacterization2medicinalproductFAMOTIDINE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, 2X/DAY

activesubstance

activesubstancenameFAMOTIDINE

openFDA Info on Medication

Application Number ANDA075400, ANDA077351, ANDA206531, ANDA090837, ANDA078916, ANDA090283, ANDA0755 ... Brand Name ACID CONTROLLER, HARRIS TEETER ACID REDUCER, HEARTBURN PREVENTION, FAMOTIDINE, R ... Generic NameFAMOTIDINEManufacturers H E B, Harris Teeter, LLC, Kroger Company, Wal-Mart Stores, Inc., Aurohealth LLC ... product_ndc 37808-301, 69256-141, 30142-194, 49035-589, 58602-705, 37808-042, 0536-1298, 646 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFAMOTIDINERXCUI 199047, 310273, 284245, 204441, 1743833, 310274, 104094, 206873, 199739, 104095, ... spl_id 1f77609d-de4d-4f77-9472-a072f8d73890, f33706dc-725a-4d6d-af1e-ede3740b1674, 5445 ... spl_set_id 813d742f-8f3d-4f18-a6c5-03eea946f976, af2c0c51-ac28-4bf4-8e60-ba6e12bfc302, c978 ... Package NDC 37808-301-65, 37808-301-72, 69256-141-65, 30142-194-71, 30142-194-02, 30142-194- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

17)

drugcharacterization2medicinalproductSPIRIVAdrugdosagetextUNK

activesubstance

activesubstancenameTIOTROPIUM BROMIDE MONOHYDRATE

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

18)

drugcharacterization2medicinalproductALBUTEROL.drugdosagetextUNK, AS NEEDED

activesubstance

activesubstancenameALBUTEROL

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

summary

narrativeincludeclinicalCASE EVENT DATE: 201402

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014096636

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use