Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10016542serious1Date Last Updated18/03/2014receiptdateformat102companynumbAT-PFIZER INC-2014074686occurcountryATseriousnessother1duplicate1Date Received17/03/2014transmissiondate02/10/2014primarysourcecountryAT

Primary Source

reportercountryATqualification1

Patient

Onset Age48Unit of Onset AgeyearsWeight102.5SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionWeight increasedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.0ReactionBody mass index increasedOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionBlood cholesterol increasedOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionBlood prolactin increasedOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionBlood triglycerides increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1575drugcumulativedosageunit003drugdosagetext125 MG, 1X/DAYdrugdosageformCAPSULE, HARDdrugstartdateformat610drugstartdate/07/2013drugenddateformat102drugenddate04/09/2013actiondrug4

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

2)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1575drugcumulativedosageunit003drugdosagetext300 MG, 1X/DAYdrugdosageformCAPSULE, HARDdrugstartdateformat102drugstartdate05/09/2013drugenddateformat102drugenddate08/09/2013actiondrug4

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

3)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb375drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1575drugcumulativedosageunit003drugdosagetext375 MG, 1X/DAYdrugdosageformCAPSULE, HARDdrugstartdateformat102drugstartdate09/09/2013drugenddateformat102drugenddate09/09/2013actiondrug4

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

4)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb450drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1575drugcumulativedosageunit003drugdosagetext450 MG, 1X/DAYdrugdosageformCAPSULE, HARDdrugstartdateformat102drugstartdate10/09/2013actiondrug4

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

5)

drugcharacterization1medicinalproductDOXAZOSIN MESILATEdrugauthorizationnumb019668drugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb80drugcumulativedosageunit003drugdosagetext4 MG, 1X/DAYdrugstartdateformat102drugstartdate10/09/2013drugenddateformat102drugenddate29/09/2013actiondrug4

6)

drugcharacterization1medicinalproductDOXAZOSIN MESILATEdrugauthorizationnumb019668drugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb80drugcumulativedosageunit003drugdosagetext8 MG, 1X/DAYdrugstartdateformat102drugstartdate30/09/2013actiondrug4

7)

drugcharacterization1medicinalproductMIRTABENEdrugstructuredosagenumb45drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb2505drugcumulativedosageunit003drugdosagetext45 MG, 1X/DAYdrugstartdateformat102drugstartdate04/09/2013drugenddateformat102drugenddate04/09/2013actiondrug1

8)

drugcharacterization1medicinalproductMIRTABENEdrugstructuredosagenumb90drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb2505drugcumulativedosageunit003drugdosagetext90 MG, 1X/DAYdrugstartdateformat102drugstartdate05/09/2013drugenddateformat102drugenddate24/09/2013actiondrug1

9)

drugcharacterization1medicinalproductMIRTABENEdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb2505drugcumulativedosageunit003drugdosagetext60 MG, 1X/DAYdrugstartdateformat102drugstartdate25/09/2013drugenddateformat102drugenddate07/10/2013actiondrug1

10)

drugcharacterization1medicinalproductMIRTABENEdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb2505drugcumulativedosageunit003drugdosagetext30 MG, 1X/DAYdrugstartdateformat102drugstartdate08/10/2013drugenddateformat102drugenddate13/10/2013actiondrug1

11)

drugcharacterization1medicinalproductCIPRALEXdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb330drugcumulativedosageunit003drugdosagetext5 MG, 1X/DAYdrugstartdateformat102drugstartdate06/09/2013drugenddateformat102drugenddate09/09/2013actiondrug4

12)

drugcharacterization1medicinalproductCIPRALEXdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb330drugcumulativedosageunit003drugdosagetext10 MG, 1X/DAYdrugstartdateformat102drugstartdate10/09/2013drugenddateformat102drugenddate10/09/2013actiondrug4

13)

drugcharacterization1medicinalproductCIPRALEXdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb330drugcumulativedosageunit003drugdosagetext20 MG, 1X/DAYdrugstartdateformat102drugstartdate11/09/2013drugenddateformat102drugenddate25/09/2013actiondrug4

14)

drugcharacterization1medicinalproductCIPRALEXdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb330drugcumulativedosageunit003drugdosagetext30 MG, 1X/DAYdrugstartdateformat102drugstartdate26/09/2013actiondrug4

15)

drugcharacterization1medicinalproductRISPERDALdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb9drugcumulativedosageunit003drugdosagetext1 MG, 1X/DAYdrugadministrationroute048drugstartdateformat102drugstartdate16/09/2013drugenddateformat102drugenddate24/09/2013actiondrug4

openFDA Info on Medication

Application NumberNDA020272, NDA020588Brand NameRISPERDALGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc 50458-300, 50458-301, 50458-302, 50458-320, 50458-330, 50458-350, 50458-395, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRISPERIDONERXCUI 104781, 104782, 104783, 104784, 199387, 211489, 262077, 262222, 312828, 312829, ... spl_idb192f7b6-639a-11ea-b722-633bfc2ca371spl_set_id7e117c7e-02fc-4343-92a1-230061dfc5e0Package NDC 50458-301-04, 50458-301-50, 50458-301-01, 50458-302-06, 50458-302-50, 50458-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

16)

drugcharacterization1medicinalproductRISPERDALdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb9drugcumulativedosageunit003drugdosagetext2 MG, 1X/DAYdrugadministrationroute048drugstartdateformat102drugstartdate25/09/2013actiondrug4

openFDA Info on Medication

Application NumberNDA020272, NDA020588Brand NameRISPERDALGeneric NameRISPERIDONEManufacturersJanssen Pharmaceuticals, Inc.product_ndc 50458-300, 50458-301, 50458-302, 50458-320, 50458-330, 50458-350, 50458-395, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRISPERIDONERXCUI 104781, 104782, 104783, 104784, 199387, 211489, 262077, 262222, 312828, 312829, ... spl_idb192f7b6-639a-11ea-b722-633bfc2ca371spl_set_id7e117c7e-02fc-4343-92a1-230061dfc5e0Package NDC 50458-301-04, 50458-301-50, 50458-301-01, 50458-302-06, 50458-302-50, 50458-302- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIL6UH7ZF8HC

17)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb200drugcumulativedosageunit003drugdosagetext150 MG, 1X/DAYdrugstartdateformat610drugstartdate/08/2013drugenddateformat102drugenddate08/09/2013

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

18)

drugcharacterization2medicinalproductSERTRALINEdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb200drugcumulativedosageunit003drugdosagetext100 MG, 1X/DAYdrugstartdateformat102drugstartdate09/09/2013drugenddateformat102drugenddate10/09/2013

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

19)

drugcharacterization2medicinalproductLAMICTALdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1275drugcumulativedosageunit003drugdosagetext50 MG, 1X/DAYdrugstartdateformat610drugstartdate/08/2013drugenddateformat102drugenddate17/09/2013

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id1a0d04ed-67ec-4e70-81fd-7b44b45a40d2, ee57c350-5f2b-46ed-8d18-a47fecd7dc28spl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIU3H27498KS

20)

drugcharacterization2medicinalproductLAMICTALdrugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1275drugcumulativedosageunit003drugdosagetext75 MG, 1X/DAYdrugstartdateformat102drugstartdate18/09/2013drugenddateformat102drugenddate22/09/2013

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id1a0d04ed-67ec-4e70-81fd-7b44b45a40d2, ee57c350-5f2b-46ed-8d18-a47fecd7dc28spl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIU3H27498KS

21)

drugcharacterization2medicinalproductLAMICTALdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1275drugcumulativedosageunit003drugdosagetext100 MG, 1X/DAYdrugstartdateformat102drugstartdate23/09/2013drugenddateformat102drugenddate01/10/2013

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id1a0d04ed-67ec-4e70-81fd-7b44b45a40d2, ee57c350-5f2b-46ed-8d18-a47fecd7dc28spl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIU3H27498KS

22)

drugcharacterization2medicinalproductLAMICTALdrugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb1275drugcumulativedosageunit003drugdosagetext200 MG, 1X/DAYdrugstartdateformat102drugstartdate02/10/2013

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id1a0d04ed-67ec-4e70-81fd-7b44b45a40d2, ee57c350-5f2b-46ed-8d18-a47fecd7dc28spl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIU3H27498KS

23)

drugcharacterization2medicinalproductRIVOTRILdrugstructuredosagenumb1.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.5 MG, 1X/DAYdrugstartdateformat102drugstartdate05/09/2013

24)

drugcharacterization2medicinalproductEXFORGEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAY, 10 TO 160 MGdrugenddateformat102drugenddate09/09/2013

openFDA Info on Medication

Application NumberNDA021990Brand NameEXFORGEGeneric NameAMLODIPINE BESYLATE AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0488, 0078-0489, 0078-0490, 0078-0491Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, VALSARTANRXCUI722126, 722131, 722134, 722137, 724879, 724887, 724891, 724895spl_ida558e3cd-df3b-4fb6-a2b2-ffc6de8817d1spl_set_idd0caec89-96ec-411d-a933-63eda74a6da7Package NDC0078-0488-15, 0078-0489-15, 0078-0490-15, 0078-0491-15NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII864V2Q084H, 80M03YXJ7I

25)

drugcharacterization2medicinalproductEXFORGEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, 1X/DAY, 5 TO 160 MGdrugstartdateformat102drugstartdate10/09/2013

openFDA Info on Medication

Application NumberNDA021990Brand NameEXFORGEGeneric NameAMLODIPINE BESYLATE AND VALSARTANManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0488, 0078-0489, 0078-0490, 0078-0491Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATE, VALSARTANRXCUI722126, 722131, 722134, 722137, 724879, 724887, 724891, 724895spl_ida558e3cd-df3b-4fb6-a2b2-ffc6de8817d1spl_set_idd0caec89-96ec-411d-a933-63eda74a6da7Package NDC0078-0488-15, 0078-0489-15, 0078-0490-15, 0078-0491-15NUIN0000000070, N0000175561Mechanism of ActionAngiotensin 2 Receptor Antagonists [MoA]Established Pharmacologic ClassAngiotensin 2 Receptor Blocker [EPC]UNII864V2Q084H, 80M03YXJ7I

26)

drugcharacterization2medicinalproductFOLSANdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 1X/DAYdrugenddateformat102drugenddate09/09/2013

27)

drugcharacterization2medicinalproductFOLSANdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, 1X/DAYdrugstartdateformat102drugstartdate10/09/2013

28)

drugcharacterization2medicinalproductFUNGORALdrugdosagetext3, THREE TIMES A WEEKdrugdosageformSHAMPOOdrugstartdateformat102drugstartdate18/09/2013drugenddateformat102drugenddate13/10/2013

29)

drugcharacterization1medicinalproductFUNGORALdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 UNK, 1X/DAYdrugdosageformCREAMdrugstartdateformat102drugstartdate18/09/2013drugenddateformat102drugenddate13/10/2013

30)

drugcharacterization2medicinalproductEBRANTILdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext60 MG, 1X/DAYdrugenddateformat102drugenddate09/09/2013

31)

drugcharacterization2medicinalproductNEBIVOLOL HYDROCHLORIDEdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, 1X/DAY

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Application NumberNDA021742Brand NameBYSTOLICGeneric NameNEBIVOLOL HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-1402, 0456-1405, 0456-1410, 0456-1420Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNEBIVOLOL HYDROCHLORIDERXCUI387013, 751612, 751616, 751618, 751620, 751623, 827073, 827075spl_idd39ebddf-024d-4b86-a95e-7a2e2b990ebfspl_set_id8b8ad213-1dc8-454e-a524-075685c0e1a8Package NDC 0456-1402-01, 0456-1402-30, 0456-1402-63, 0456-1402-90, 0456-1405-01, 0456-1405- ... UNIIJGS34J7L9I

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duplicatesourcePFIZERduplicatenumbAT-PFIZER INC-2014074686

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receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use