Adverse Event Report

Report

Version of Safety Report ID7Safety Report ID10468191primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate06/02/2017reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received22/09/2014receiptdateformat102Date Last Updated09/11/2016fulfillexpeditecriteria1companynumbUS-PFIZER INC-2014261269duplicate1

Report Duplicate

duplicatesourcePFIZERduplicatenumbUS-PFIZER INC-2014261269

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight136.9SexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionGait disturbanceOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.1ReactionArthropathyOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt19.1ReactionHypokinesiaOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionPainOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.1ReactionDrug ineffectiveOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionArthropathyOutcomeNot recovered/not resolved

7)

reactionmeddraversionpt19.1ReactionPancreatitisOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductVITAMIN D3drugstructuredosagenumb6000drugstructuredosageunit012drugdosagetext6000 ML, DAILY

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

2)

drugcharacterization2medicinalproductLABETALOL HCLdrugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MG, 2X/DAYdrugdosageformTABLETdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameLABETALOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075113, ANDA200908Brand NameLABETALOL HCLGeneric NameLABETALOL HCL, LABETALOL HYDROCHLORIDEManufacturersEon Labs, Inc., Par Pharmaceutical, Inc.product_ndc0185-0010, 0185-0117, 0185-0118, 49884-122, 49884-123, 49884-124Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLABETALOL HYDROCHLORIDERXCUI896758, 896762, 896766spl_ida4c308a8-e7f2-4f2f-b2f5-2cf74022a372, c2fd5bf2-ce6b-48a7-a782-17dd1df2d326spl_set_id1111acdb-1f6a-4b5e-955b-a50efe998914, 56ab2ff4-14a6-4297-afd8-56b92e1f64a0Package NDC 0185-0010-10, 0185-0010-05, 0185-0010-01, 0185-0117-10, 0185-0117-05, 0185-0117- ... UNII1GEV3BAW9J

3)

drugcharacterization2medicinalproductHUMIRAdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext40 MG/ 0.8ML, WEEKLYdrugdosageformINJECTIONdrugstartdateformat102drugstartdate15/05/2009

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_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

4)

drugcharacterization1medicinalproductLYRICAdrugbatchnumbL68171drugauthorizationnumb021446drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb472500drugcumulativedosageunit003drugdosagetext75 MG, 3X/DAYdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationFIBROMYALGIAdrugstartdateformat102drugstartdate14/02/2008drugenddateformat102drugenddate01/09/2014actiondrug1drugadditional1

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, bfdec19d-6a54-449c-95b4-908d28e5369aspl_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)

drugcharacterization2medicinalproductACCUPRILdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, DAILYdrugdosageformTABLETdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameQUINAPRIL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA019885Brand NameACCUPRILGeneric NameQUINAPRIL HYDROCHLORIDEManufacturersParke-Davis Div of Pfizer Incproduct_ndc 0071-0527, 0071-0530, 0071-0532, 0071-0535, 0071-1205, 0071-1410, 0071-1620, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUINAPRIL HYDROCHLORIDERXCUI207891, 207892, 207893, 207895, 312748, 312749, 312750, 314203spl_id44db5578-5817-49f8-bc11-88f018bcbb6cspl_set_id63cf5651-d52c-4d27-9fd4-ed9cd9724dffPackage NDC 0071-0527-23, 0071-0530-23, 0071-0530-40, 0071-0532-23, 0071-0532-40, 0071-0535- ... UNII33067B3N2M

6)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugcumulativedosagenumb472500drugcumulativedosageunit003drugdosageformCAPSULE, HARDdrugindicationPAINactiondrug1drugadditional1

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, bfdec19d-6a54-449c-95b4-908d28e5369aspl_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

7)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, DAILYdrugdosageformTABLETdrugindicationBLOOD CHOLESTEROL ABNORMALdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_idb95993d7-bc87-4d0a-9926-e3d36c5b3b4espl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-97, 0071-0156-23, 0071-0156-40, 0071-0156- ... UNII48A5M73Z4Q

8)

drugcharacterization2medicinalproductNITRODISCdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext0.2MG/HR PATCH 24HRdrugdosageformTRANSDERMAL PATCHdrugadministrationroute062

activesubstance

activesubstancenameNITROGLYCERIN

9)

drugcharacterization2medicinalproductCANASAdrugstructuredosagenumb1000drugstructuredosageunit003drugdosagetext1000 MG, DAILYdrugadministrationroute048drugstartdateformat102drugstartdate03/02/2009

activesubstance

activesubstancenameMESALAMINE

openFDA Info on Medication

Application NumberNDA021252Brand NameCANASAGeneric NameMESALAMINEManufacturersAllergan, Inc.product_ndc58914-501Product TypeHUMAN PRESCRIPTION DRUGRouteRECTALActive IngredientsMESALAMINERXCUI248420, 583257spl_id32ad7fad-3fe0-4413-baac-a243c1548e98spl_set_id89d91601-152b-4398-bebe-af1c023e9935Package NDC58914-501-56, 58914-501-42, 58914-501-33NUIN0000175781, M0000971Established Pharmacologic ClassAminosalicylate [EPC]Chemical StructureAminosalicylic Acids [CS]UNII4Q81I59GXC

10)

drugcharacterization2medicinalproductALLEGRA ALLERGYdrugstructuredosagenumb180drugstructuredosageunit003drugdosagetext180 MG, DAILYdrugdosageformTABLETdrugstartdateformat102drugstartdate12/02/2015

activesubstance

activesubstancenameFEXOFENADINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020872Brand NameALLEGRA ALLERGYGeneric NameFEXOFENADINE HYDROCHLORIDEManufacturersChattem, Inc., Lil' Drug Store Products, Incproduct_ndc41167-4120, 41167-4131, 41167-4121, 41167-4124, 41167-4122, 66715-9707Product TypeHUMAN OTC DRUGRouteORALActive IngredientsFEXOFENADINE HYDROCHLORIDERXCUI997420, 997422, 997501, 997502spl_id 9800af50-0358-4ad3-8980-8e986df31e81, 7b02cf6b-1e6e-429f-997b-991fc71b852e, c6f2 ... spl_set_id 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173, f061d6b1-89f7-4d5f-ac59-9c73408517c1, b82d ... Package NDC 41167-4131-2, 41167-4131-4, 41167-4131-6, 41167-4120-1, 41167-4120-0, 41167-4120 ... UNII2S068B75ZU

11)

drugcharacterization2medicinalproductNITROSTATdrugstructuredosagenumb.4drugstructuredosageunit003drugdosagetext0.4MG 1 SL Q 5 MINS X 3 PRNdrugadministrationroute060drugindicationCHEST PAINdrugstartdateformat102drugstartdate21/02/2007

activesubstance

activesubstancenameNITROGLYCERIN

openFDA Info on Medication

Application NumberNDA021134Brand NameNITROSTATGeneric NameNITROGLYCERINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0417, 0071-0418, 0071-0419Product TypeHUMAN PRESCRIPTION DRUGRouteSUBLINGUALActive IngredientsNITROGLYCERINRXCUI198038, 198039, 198040, 207331, 207346, 207361spl_idb21bdc0d-86ca-4a5f-9695-a7a8064f5bedspl_set_id79ba021e-183c-4b4d-822e-4ff5ef54ca61Package NDC0071-0417-24, 0071-0418-24, 0071-0418-13, 0071-0419-24NUIN0000175415, M0014874, N0000009909Established Pharmacologic ClassNitrate Vasodilator [EPC]Chemical StructureNitrates [CS]Physiologic/Pharmacodynamic EffectVasodilation [PE]UNIIG59M7S0WS3

12)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG, EVERY MORNINGdrugdosageformTABLETdrugstartdateformat102drugstartdate23/02/2015

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 857dd673-6ba8-485c-b96b-14291666b852, 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

13)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, 2X/DAYdrugdosageformTABLET

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 857dd673-6ba8-485c-b96b-14291666b852, 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

14)

drugcharacterization2medicinalproductASACOLdrugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb4drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext800 MG, 4X/DAYdrugdosageformTABLETdrugstartdateformat102drugstartdate05/06/2006

activesubstance

activesubstancenameMESALAMINE

15)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10MG 1 Q HS PRNdrugindicationMUSCLE SPASMSdrugstartdateformat102drugstartdate25/01/2008

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

16)

drugcharacterization2medicinalproductPREMARINdrugdosagetext0.625 MG/GM, 1/2 APPLICATOR PER VAGINA 2 NIGHTS /WEEKdrugdosageformVAGINAL CREAMdrugadministrationroute067drugindicationATROPHIC VULVOVAGINITISdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameESTROGENS, CONJUGATED

openFDA Info on Medication

Application NumberNDA020216, NDA010402, NDA004782Brand NamePREMARIN VAGINAL, PREMARINGeneric NameCONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0046-0872, 0046-0749, 0046-1100, 0046-1101, 0046-1102, 0046-1104, 0046-1103Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, INTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsESTROGENS, CONJUGATEDRXCUI 688240, 688242, 211975, 310203, 150840, 197660, 197661, 197662, 202301, 208513, ... spl_id b54269c0-58cc-40b9-80fe-91740e9ed83f, 73618f81-e08d-4f94-807c-8a58395ec2a2, 9cd6 ... spl_set_id 96609623-528e-4aba-cabe-7254aed816d5, 87e2da8d-432c-4ed5-67a1-dc26294b2295, 258e ... Package NDC 0046-0872-04, 0046-0872-21, 0046-0749-05, 0046-1101-81, 0046-1102-81, 0046-1102- ... NUIN0000175825, N0000000100, M0007792Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]Chemical StructureEstrogens, Conjugated (USP) [CS]UNIIIU5QR144QX

17)

drugcharacterization2medicinalproductVITAMIN D 25-HYDROXYdrugdosagetextUNKdrugindicationARTHRALGIA

18)

drugcharacterization2medicinalproductDILTIAZEM HCLdrugstructuredosagenumb240drugstructuredosageunit003drugdosagetext240 MG, DAILYdrugdosageformPROLONGED-RELEASE CAPSULEdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameDILTIAZEM HYDROCHLORIDE

19)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3MG, 1 QHS, PRNdrugindicationINSOMNIAdrugstartdateformat102drugstartdate15/05/2009

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

20)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugstructuredosagenumb75drugstructuredosageunit003drugcumulativedosagenumb472500drugcumulativedosageunit003drugdosagetext75 MG, 1 (ONE) CAPSULE BY MOUTH THREE TIMES A DAY AS NEEDEDdrugdosageformCAPSULE, HARDdrugadministrationroute048drugindicationNERVE INJURYactiondrug1drugadditional1

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, bfdec19d-6a54-449c-95b4-908d28e5369aspl_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

21)

drugcharacterization2medicinalproductDITROPAN XLdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, 24 DAILYdrugdosageformPROLONGED-RELEASE TABLETdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameOXYBUTYNIN CHLORIDE

openFDA Info on Medication

Application NumberNDA020897Brand NameDITROPAN XLGeneric NameOXYBUTYNIN CHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-805, 50458-810Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYBUTYNIN CHLORIDERXCUI863619, 863622, 863636, 863638spl_id648afd98-b6a3-11ec-9bb8-8a5bdd42b7b5spl_set_id36cc9115-bef3-48fa-93ff-bcda24cf26e2Package NDC50458-805-01, 50458-810-01UNIIL9F3D9RENQ

22)

drugcharacterization2medicinalproductHYDROXYZINE HCLdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, 2X/DAYdrugdosageformTABLETdrugstartdateformat102drugstartdate14/01/2015

activesubstance

activesubstancenameHYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

23)

drugcharacterization2medicinalproductPROVENTIL HFAdrugstructuredosagenumb2drugstructuredosageunit032drugdosagetext2 DF, AS NEEDEDdrugindicationWHEEZINGdrugstartdateformat102drugstartdate12/11/2012

activesubstance

activesubstancenameALBUTEROL SULFATE

openFDA Info on Medication

Application NumberNDA020503Brand NamePROVENTIL HFAGeneric NameALBUTEROL SULFATEManufacturersMerck Sharp & Dohme Corp., Sandozproduct_ndc0085-1132, 66758-959Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI746763, 2123111spl_idbd0c720f-c140-401e-e053-2a95a90a970d, c3df223b-6572-dbb1-e053-2995a90aa438spl_set_id0f8fd0fb-97bc-479e-a9e9-104ea7b230e7, 917b6148-61f2-4e4d-9560-d261bac97060Package NDC0085-1132-04, 66758-959-85UNII021SEF3731

24)

drugcharacterization1medicinalproductLYRICAdrugauthorizationnumb021446drugcumulativedosagenumb472500drugcumulativedosageunit003drugdosageformCAPSULE, HARDdrugindicationNEURALGIAactiondrug1drugadditional1

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, bfdec19d-6a54-449c-95b4-908d28e5369aspl_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

25)

drugcharacterization2medicinalproductHYDROCODONEdrugstructuredosagenumb500drugstructuredosageunit003drugdosagetext500 MG, AS NEEDED

activesubstance

activesubstancenameHYDROCODONE

26)

drugcharacterization2medicinalproductVITAMIN D2drugstructuredosagenumb50000drugstructuredosageunit025drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext50000 IU, WEEKLYdrugstartdateformat610drugstartdate/04/2015

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

27)

drugcharacterization2medicinalproductZANTACdrugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext150 MG, 2X/DAYdrugdosageformTABLETdrugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameRANITIDINE HYDROCHLORIDE

28)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, 1X/DAYdrugdosageformTABLETdrugstartdateformat602drugstartdate//2012

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 857dd673-6ba8-485c-b96b-14291666b852, 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

29)

drugcharacterization2medicinalproductFLONASEdrugstructuredosagenumb4drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 DF, 1X/DAYdrugdosageformNASAL SPRAY, SUSPENSIONdrugadministrationroute045drugstartdateformat102drugstartdate23/02/2015

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA205434, part341Brand NameFLONASE ALLERGY RELIEF, FLONASE HEADACHE AND ALLERGY RELIEFGeneric Name FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE H ... ManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576, 0135-0578Product TypeHUMAN OTC DRUGRouteNASAL, ORALActive Ingredients FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE H ... RXCUI1797907, 1797933, 1046781spl_id1f0c6c8a-8452-45ae-8ed6-517e855d70b9, 282c103c-3888-4a35-a5b1-d492ed6892c1spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1d, 282c103c-3888-4a35-a5b1-d492ed6892c1Package NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W, 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ

30)

drugcharacterization2medicinalproductASPIRIN (E.C.)drugstructuredosagenumb325drugstructuredosageunit003drugdosagetext325 MG, DAILYdrugstartdateformat102drugstartdate18/08/2005

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

summary

narrativeincludeclinicalCASE EVENT DATE: 20120107