Adverse Event Report

Report

reporttype2Version of Safety Report ID16receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10042590serious1Date Last Updated16/11/2018receiptdateformat102companynumbPHHY2014BR035893occurcountryBRseriousnessother1duplicate1Date Received27/03/2014seriousnesshospitalization1transmissiondate04/02/2019primarysourcecountryBR

Primary Source

reportercountryBRqualification3

Patient

Onset Age58Unit of Onset AgeyearsWeight98SexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionVomitingOutcomeRecovering/resolving

2)

reactionmeddraversionpt21.1ReactionDizzinessOutcomeRecovering/resolving

3)

reactionmeddraversionpt21.1ReactionNauseaOutcomeRecovered/resolved

4)

reactionmeddraversionpt21.1ReactionInsomniaOutcomeRecovered/resolved

5)

reactionmeddraversionpt21.1ReactionBlood pressure fluctuationOutcomeRecovered/resolved

6)

reactionmeddraversionpt21.1ReactionWeight decreasedOutcomeRecovering/resolving

7)

reactionmeddraversionpt21.1ReactionNeoplasm progressionOutcomeUnknown

8)

reactionmeddraversionpt21.1ReactionNauseaOutcomeRecovering/resolving

9)

reactionmeddraversionpt21.1ReactionImmunodeficiencyOutcomeUnknown

10)

reactionmeddraversionpt21.1ReactionDrug ineffectiveOutcomeUnknown

11)

reactionmeddraversionpt21.1ReactionPainOutcomeRecovered/resolved

12)

reactionmeddraversionpt21.1ReactionNauseaOutcomeRecovered/resolved

13)

reactionmeddraversionpt21.1ReactionSomnolenceOutcomeRecovering/resolving

14)

reactionmeddraversionpt21.1ReactionDiarrhoeaOutcomeRecovering/resolving

15)

reactionmeddraversionpt21.1ReactionPancreatitisOutcomeRecovering/resolving

16)

reactionmeddraversionpt21.1ReactionPancreatic enzymes decreasedOutcomeRecovered/resolved

17)

reactionmeddraversionpt21.1ReactionMalignant neoplasm progressionOutcomeUnknown

18)

reactionmeddraversionpt21.1ReactionInappropriate schedule of product administrationOutcomeUnknown

19)

reactionmeddraversionpt21.1ReactionHypokalaemiaOutcomeRecovered/resolved

20)

reactionmeddraversionpt21.1ReactionDiarrhoeaOutcomeRecovered/resolved

21)

reactionmeddraversionpt21.1ReactionInjection site painOutcomeRecovering/resolving

22)

reactionmeddraversionpt21.1ReactionVomitingOutcomeRecovered/resolved

23)

reactionmeddraversionpt21.1ReactionDiarrhoeaOutcomeRecovered/resolved

24)

reactionmeddraversionpt21.1ReactionInfluenzaOutcomeUnknown

25)

reactionmeddraversionpt21.1ReactionRenal painOutcomeNot recovered/not resolved

26)

reactionmeddraversionpt21.1ReactionVomitingOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosagetext30 MG (1 AMPOULE), QMO (EVERY 28 DAYS)drugdosageformSUSPENSIONdrugadministrationroute030drugindicationPANCREATIC NEUROENDOCRINE TUMOURdrugstartdateformat610drugstartdate/06/2014actiondrug3

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

2)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugbatchnumbSC826drugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugdosageformSUSPENSIONdrugadministrationroute030actiondrug3

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

3)

drugcharacterization2medicinalproductPROPANOLOLdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BIDdrugdosageformTABLETdrugadministrationroute048actiondrug3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

4)

drugcharacterization2medicinalproductCREONdrugbatchnumbA4940202drugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 DF, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationPANCREATIC ENZYMES DECREASEDdrugstartdateformat610drugstartdate/07/2014actiondrug4

activesubstance

activesubstancenamePANCRELIPASE AMYLASE\PANCRELIPASE LIPASE\PANCRELIPASE PROTEASE

openFDA Info on Medication

Application NumberBLA020725Brand NameCREONGeneric NamePANCRELIPASEManufacturersAbbVie Inc.product_ndc0032-1203, 0032-1206, 0032-1212, 0032-1224, 0032-3016Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANCRELIPASE AMYLASE, PANCRELIPASE LIPASE, PANCRELIPASE PROTEASERXCUI 855495, 855499, 855503, 863829, 863836, 863841, 1113042, 1113046, 1373325, 13733 ... spl_id3dd173f8-17c2-a84f-82ac-099909ba9ef0spl_set_id073201aa-556d-4a70-918e-84e9616fd88dPackage NDC 0032-1206-07, 0032-1206-01, 0032-1206-56, 0032-1212-07, 0032-1212-01, 0032-1212- ... UNII8MYC33932O, 3560D81V50, YOJ58O116E

5)

drugcharacterization2medicinalproductPROPANOLOLdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute065drugindicationHYPERTENSIONactiondrug3

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

6)

drugcharacterization2medicinalproductSERTRALINEdrugdosageformTABLETdrugindicationDEPRESSIONactiondrug4

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

7)

drugcharacterization2medicinalproductDIAZEPAM.drugdosagetext5 OT, UNKdrugdosageformTABLETdrugadministrationroute048actiondrug2drugadditional1

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

8)

drugcharacterization2medicinalproductDIAZEPAM.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugdosageformTABLETdrugadministrationroute048actiondrug2drugadditional1

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

9)

drugcharacterization1medicinalproductXELODAdrugadministrationroute065drugindicationNEUROENDOCRINE TUMOURactiondrug5drugadditional3

activesubstance

activesubstancenameCAPECITABINE

openFDA Info on Medication

Application NumberNDA020896Brand NameXELODAGeneric NameCAPECITABINEManufacturersGenentech, Inc.product_ndc0004-1100, 0004-1101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCAPECITABINERXCUI200327, 200328, 213292, 213293spl_id7228932d-2f21-49d5-bcda-f7bf19928afdspl_set_ida1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8Package NDC0004-1100-20, 0004-1101-50NUIN0000000233, N0000175595Mechanism of ActionNucleic Acid Synthesis Inhibitors [MoA]Established Pharmacologic ClassNucleoside Metabolic Inhibitor [EPC]UNII6804DJ8Z9U

10)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, UNKdrugdosageformTABLETdrugadministrationroute048drugindicationANXIETYdrugstartdateformat602drugstartdate//2012actiondrug4

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

11)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, DAILY SPORADICALLYdrugdosageformTABLETdrugadministrationroute065drugindicationPAIN PROPHYLAXISdrugstartdateformat610drugstartdate/02/2014actiondrug5drugadditional3

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

12)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext75 MG, QD (1 TABLET)drugdosageformTABLETdrugadministrationroute048drugindicationFIBROMYALGIAactiondrug1drugadditional1

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, 0fbd5d1f-30cd-464d-a1d6-71e8057a9377spl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

13)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosagetext20MG (1 AMPOULE), QMO (EVERY 28 DAYS)drugdosageformSUSPENSIONdrugadministrationroute030drugstartdateformat610drugstartdate/11/2015drugenddateformat610drugenddate/03/2016actiondrug3

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

14)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, EVERY 20 DAYSdrugdosageformSUSPENSIONdrugadministrationroute030drugstartdateformat102drugstartdate30/10/2018actiondrug3

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

15)

drugcharacterization2medicinalproductINFLUENZA A (H1N1) 2009 MONOVALENT VACCINEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancename INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVAT ...

16)

drugcharacterization2medicinalproductINFLUENZA A (H1N1) 2009 MONOVALENT VACCINEdrugdosagetextUNKdrugadministrationroute065drugstartdateformat102drugstartdate09/05/2014actiondrug5drugadditional3

activesubstance

activesubstancename INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVAT ...

17)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosagetext30 MG (1 AMPOULE), QMO (EVERY 28 DAYS)drugdosageformSUSPENSIONdrugadministrationroute030drugindicationNEUROENDOCRINE TUMOURdrugstartdateformat610drugstartdate/11/2012drugenddateformat610drugenddate/02/2014actiondrug3

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

18)

drugcharacterization1medicinalproductOXALIPLATIN.drugadministrationroute065drugindicationNEUROENDOCRINE TUMOURactiondrug5drugadditional3

activesubstance

activesubstancenameOXALIPLATIN

openFDA Info on Medication

Application Number ANDA208523, ANDA207325, ANDA203869, ANDA207474, ANDA204616, ANDA078803, ANDA2043 ... Brand NameOXALIPLATINGeneric NameOXALIPLATINManufacturers Cipla USA Inc., Fosun Pharma USA Inc., Gland Pharma Limited, Meitheal Pharmaceut ... product_ndc 69097-274, 69097-353, 72266-161, 72266-162, 68083-176, 68083-177, 68083-314, 712 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsOXALIPLATINRXCUI1736776, 1736781, 1797528, 1736784, 1736786spl_id 1f8ee714-a349-45a1-9b9a-337c16441498, a06da3b2-b526-ed03-e053-2995a90a5207, 6e08 ... spl_set_id 5ffb166a-8283-44c0-8590-ecad2743c154, fad0f147-6595-4412-87a7-2afca0192a96, a6f8 ... Package NDC 69097-274-37, 69097-353-78, 72266-161-01, 72266-162-01, 68083-176-01, 68083-177- ... NUIN0000175413, N0000175073Established Pharmacologic ClassPlatinum-based Drug [EPC]UNII04ZR38536J

19)

drugcharacterization2medicinalproductFLUOXETINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute065drugindicationANXIETYactiondrug1drugadditional1

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090223, ANDA209695, ANDA078619, ANDA079209, ANDA210935, ANDA211282, ANDA2132 ... Brand NameFLUOXETINEGeneric NameFLUOXETINE, FLUOXETINE HYDROCHLORIDEManufacturers Alembic Pharmaceuticals Limited, Nivagen Pharmaceuticals, Inc., BluePoint Labora ... product_ndc 46708-271, 46708-272, 46708-273, 75834-148, 68001-399, 68001-400, 68001-401, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI310384, 310385, 313989, 1190110, 310386, 248642, 313990spl_id 40ef6547-f80f-45f4-8719-ebc913b4df7d, 789b1507-b5c0-4a50-bf82-f1fe9bb3c8d6, b697 ... spl_set_id 6b9c2d73-866b-44c4-8718-e7e4a9a0fb55, f4cbf9a9-1d7f-4aa0-a18d-fba50d49bd2b, f89a ... Package NDC 46708-271-30, 46708-271-31, 46708-271-71, 46708-271-91, 46708-272-30, 46708-272- ... UNIII9W7N6B1KJ

20)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSIONactiondrug4

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 9d73930e-75b8-4a7b-9d12-2049f593ca9d, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

21)

drugcharacterization2medicinalproductDIAZEPAM.drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNKdrugdosageformTABLETdrugadministrationroute048drugindicationINSOMNIAdrugstartdateformat610drugstartdate/03/2012actiondrug2drugadditional1

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMRXCUI 1807459, 197589, 197590, 197591, 1807452, 2120550, 801957, 801961, 801966, 22726 ... spl_id c2374258-57c6-4be5-89df-27d6cf5dc832, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 8861 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

22)

drugcharacterization1medicinalproductSANDOSTATIN LAR DEPOTdrugauthorizationnumb021008drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosagetext20 MG, QMO (QMO (EVERY 28 DAYS))drugdosageformSUSPENSIONdrugadministrationroute030actiondrug3

activesubstance

activesubstancenameOCTREOTIDE ACETATE

openFDA Info on Medication

Application NumberNDA021008Brand NameSANDOSTATIN LAR DEPOTGeneric NameOCTREOTIDE ACETATEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0811, 0078-0818, 0078-0825Product TypeHUMAN PRESCRIPTION DRUGRXCUI898589, 898591, 898601, 898603, 898605, 898607spl_id13642792-8dbc-43c5-a5b5-ced9df3c30caspl_set_idd0b7fe9e-7000-4b79-ba3b-291ce92c14f9Package NDC 0078-0811-81, 0078-0790-61, 0078-0818-81, 0078-0797-61, 0078-0825-81, 0078-0804- ...

summary

narrativeincludeclinicalCASE EVENT DATE: 2012

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2014BR035893

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use