Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID12421913primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/02/2019reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received31/05/2016receiptdateformat102Date Last Updated27/12/2018fulfillexpeditecriteria1companynumbUS-DSJP-DSU-2016-108470duplicate1

Report Duplicate

duplicatesourceDAIICHIduplicatenumbUS-DSJP-DSU-2016-108470

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Reaction

1)

reactionmeddraversionpt21.1ReactionAcquired oesophageal webOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionDiverticulumOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt21.1ReactionHaemorrhoidsOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt21.1ReactionIrritable bowel syndromeOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt21.1ReactionBarrett^s oesophagusOutcomeUnknown

6)

reactionmeddraversionpt21.1ReactionProduct administration errorOutcomeUnknown

7)

reactionmeddraversionpt21.1ReactionSyncopeOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt21.1ReactionGastrooesophageal reflux diseaseOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt21.1ReactionSprue-like enteropathyOutcomeNot recovered/not resolved

10)

reactionmeddraversionpt21.1ReactionAcute kidney injuryOutcomeUnknown

11)

reactionmeddraversionpt21.1ReactionPolypOutcomeRecovered/resolved

12)

reactionmeddraversionpt21.1ReactionOff label useOutcomeUnknown

13)

reactionmeddraversionpt21.1ReactionCoeliac diseaseOutcomeUnknown

14)

reactionmeddraversionpt21.1ReactionHiatus herniaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductBENICARdrugauthorizationnumb021286drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MGdrugdosageformTABLETdrugstartdateformat102drugstartdate10/03/2014actiondrug1drugadditional1

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

2)

drugcharacterization2medicinalproductCRESTORdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugindicationBLOOD CHOLESTEROL

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

3)

drugcharacterization2medicinalproductZEGERID /00661201/drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugindicationDYSPEPSIA

activesubstance

activesubstancenameOMEPRAZOLE

4)

drugcharacterization1medicinalproductBENICARdrugauthorizationnumb021286drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugdosageformTABLETdrugindicationCARDIAC DISORDERdrugstartdateformat102drugstartdate01/01/2008drugenddateformat610drugenddate/03/2016actiondrug1drugadditional1

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

5)

drugcharacterization1medicinalproductBENICARdrugauthorizationnumb021286drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG HALF TABLET, QDdrugdosageformTABLETactiondrug1drugadditional1

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

6)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, QDdrugindicationINSOMNIA

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

7)

drugcharacterization2medicinalproductMETHOCARBAMOL.drugstructuredosagenumb750drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext750 MG, QDdrugindicationMUSCLE RELAXANT THERAPY

activesubstance

activesubstancenameMETHOCARBAMOL

openFDA Info on Medication

Application Number ANDA200958, ANDA207522, ANDA204404, ANDA208507, ANDA040489, ANDA211504, ANDA2126 ... Brand Name METHOCARBAMOL, METHOCARBAMOL TABLETS, USP, 500 MG, METHOCARBAMOL TABLETS, USP, 7 ... Generic NameMETHOCARBAMOL, METHOCARBAMOL TABLETSManufacturers Westminster Pharmaceuticals, LLC, Somerset Therapeutics, LLC, Mylan Institutiona ... product_ndc 69367-255, 69367-256, 70069-101, 67457-273, 76385-123, 76385-124, 70868-901, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHOCARBAMOLRXCUI197943, 197944, 238175, 207014spl_id ae9df131-66a3-0ec7-e053-2995a90a02e4, 77cf2a2b-e3af-4755-8923-5226b81aea5c, b0da ... spl_set_id 2199b810-fb84-4dac-b787-ade2b5f67e92, 68dd9c24-4d41-48be-9f54-fceb787bb443, 14d9 ... Package NDC 69367-256-01, 69367-256-05, 69367-255-01, 69367-255-05, 70069-101-01, 70069-101- ... NUIN0000175730, N0000175737Physiologic/Pharmacodynamic EffectCentrally-mediated Muscle Relaxation [PE]Established Pharmacologic ClassMuscle Relaxant [EPC]UNII125OD7737X

8)

drugcharacterization2medicinalproductVIVELLE-DOTdrugstructuredosagenumb.075drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.075 MG, QDdrugadministrationroute062

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application NumberNDA020538Brand NameVIVELLE-DOTGeneric NameESTRADIOLManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0343, 0078-0365, 0078-0344, 0078-0345, 0078-0346Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsESTRADIOLRXCUI241946, 242891, 242892, 248478, 284378, 310172, 310176, 310183, 1149632, 1149634spl_idf7a35df4-8f6a-4d7d-8249-220d3d36cb81spl_set_ide6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbfPackage NDC 0078-0365-62, 0078-0365-42, 0078-0365-45, 0078-0343-62, 0078-0343-42, 0078-0343- ... NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E

9)

drugcharacterization2medicinalproductFENOFIBRATE.drugstructuredosagenumb135drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext135 MG, QDdrugindicationBLOOD CHOLESTEROL

activesubstance

activesubstancenameFENOFIBRATE

openFDA Info on Medication

Application Number ANDA211080, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA090715, NDA02169 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, LIPOFEN, FENOGLIDEGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Amneal Pharmaceuticals NY LLC, Northstar Rx LLC, Gravi ... product_ndc 43547-430, 43547-431, 69238-1262, 69238-1263, 16714-739, 16714-740, 16714-741, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 349287, 351133, 200311, 310288, 310289, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, eabb010f-d348-4d41-afac-20c21ef60800, 502b ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 7e79d495-5d59-485e-b3c2-7c31ba044948, e47b ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 69238-1262-9, 69238-1263 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

10)

drugcharacterization2medicinalproductCARDIZEMdrugstructuredosagenumb360drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext360 MG, QDdrugindicationHYPERTENSION

activesubstance

activesubstancenameDILTIAZEM HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018602Brand NameCARDIZEMGeneric NameDILTIAZEM HYDROCHLORIDEManufacturersBausch Health US LLCproduct_ndc0187-0771, 0187-0772, 0187-0791, 0187-0792Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDILTIAZEM HYDROCHLORIDERXCUI831054, 831055, 831102, 831103, 831137, 833217, 833219, 834393spl_id73b78511-8da0-42c4-bf53-1158d748bfbdspl_set_idf3e7ecef-f360-4987-a4f5-933214130ab2Package NDC0187-0771-47, 0187-0771-55, 0187-0772-47, 0187-0791-47, 0187-0792-47UNIIOLH94387TE

11)

drugcharacterization2medicinalproductAVELOXdrugstructuredosagenumb400drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 MG, QDdrugindicationANTIBIOTIC THERAPY

activesubstance

activesubstancenameMOXIFLOXACIN HYDROCHLORIDE

12)

drugcharacterization2medicinalproductACETAMINOPHEN W/HYDROCODONEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext7.5/750 MG, QDdrugindicationPAIN

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE

13)

drugcharacterization2medicinalproductALPRAZOLAM.drugstructuredosagenumb.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.5 MG, QDdrugindicationANXIETY

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

14)

drugcharacterization2medicinalproductPROMETHAZINEdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext25 MG, QDdrugindicationNAUSEA

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040882Brand NamePROMETHAZINE HYDROCHLORIDEGeneric NamePROMETHAZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-678Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992432spl_id43553934-cb17-455f-bb9a-3f44b9da0cbbspl_set_idafb16e94-03bf-4ea2-b2fe-e65f274e55a9Package NDC65162-678-86, 65162-678-90UNIIR61ZEH7I1I

15)

drugcharacterization2medicinalproductMETHYLPREDNISOLONE.drugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETHYLPREDNISOLONE

openFDA Info on Medication

Application Number NDA011153, ANDA209097, ANDA040189, ANDA040194, ANDA204072, ANDA212262, ANDA04018 ... Brand NameMEDROL, METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATEGeneric NameMETHYLPREDNISOLONEManufacturers Pharmacia and Upjohn Company LLC, Lupin Pharmaceuticals, Inc., BluePoint Laborat ... product_ndc 0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 68180-685, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATERXCUI 197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, ... spl_id 8f9c2163-1d7f-4e6e-bbe5-d758de474744, c71a649a-a46d-4e69-81b8-f65e77a4c48b, 6135 ... spl_set_id 39d5270b-d957-4821-93d6-501b7b9f02d4, c5cbcea1-2200-4fc0-a49a-35edd9434873, a91f ... Package NDC 0009-0049-02, 0009-0056-02, 0009-0056-04, 0009-0022-01, 0009-0073-01, 0009-0176- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023, LEC9GKY20K

16)

drugcharacterization2medicinalproductPAROXETINE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugindicationANTIDEPRESSANT DRUG CLEARANCE

activesubstance

activesubstancenamePAROXETINE

openFDA Info on Medication

Application Number ANDA209293, ANDA077584, ANDA207188, ANDA075356, ANDA078406, NDA204516, ANDA20385 ... Brand NamePAROXETINE, BRISDELLEGeneric NamePAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, PAROXETINEManufacturers Rhodes Pharmaceuticals L.P., Cadila Healthcare Limited, Solco Healthcare LLC, Ap ... product_ndc 42858-703, 42858-705, 42858-707, 65841-097, 65841-098, 65841-099, 65841-601, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE ANHYDROUS, PAROXE ... RXCUI 1738803, 1738805, 1738807, 1738483, 1738495, 1738503, 1738511, 1430122, 312242, ... spl_id 06f6d078-40c3-46f3-a245-28ad27f2dc37, 6a265e0a-6487-457a-83ef-b5303dfe6beb, 3f62 ... spl_set_id f562ab1a-adb9-4154-81cd-ceb480234331, 6d5fcdb2-4d84-4b20-87e3-58a43e567500, 2c58 ... Package NDC 42858-703-03, 42858-703-50, 42858-705-03, 42858-705-50, 42858-707-03, 42858-707- ... UNIIX2ELS050D8, 3I3T11UD2S, M711N184JE

17)

drugcharacterization2medicinalproductVERAPAMILdrugstructuredosagenumb320drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext320 MG, QDdrugindicationHYPERTENSION

activesubstance

activesubstancenameVERAPAMIL HYDROCHLORIDE

18)

drugcharacterization2medicinalproductKLOR-CONdrugstructuredosagenumb20drugstructuredosageunit029drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MEQ, QDdrugindicationBLOOD POTASSIUM

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Application NumberNDA019123, ANDA209662Brand NameKLOR-CONGeneric NamePOTASSIUM CHLORIDEManufacturersUpsher-Smith Laboratories, LLCproduct_ndc0245-5315, 0245-5316, 0245-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CHLORIDERXCUI312529, 628953, 628958, 832718, 1867544, 1867547spl_id0907ea1c-82f3-4ba8-9d1b-3f4fa104d7a2, d9472735-27e8-4597-92f4-0b9afaaaa0a4spl_set_id1ff53330-065c-4213-9c0c-ac498621d09d, e61a4522-b91d-400a-952c-6f035e4610ddPackage NDC 0245-5315-11, 0245-5315-15, 0245-5315-89, 0245-5315-01, 0245-5316-11, 0245-5316- ... UNII660YQ98I10

19)

drugcharacterization1medicinalproductBENICARdrugauthorizationnumb021286drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugdosageformTABLETdrugindicationHYPERTENSIONdrugstartdateformat102drugstartdate01/01/2008drugenddateformat102drugenddate10/03/2014actiondrug1drugadditional1

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

20)

drugcharacterization2medicinalproductVIVELLE-DOTdrugstructuredosagenumb.1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.1 MG, QDdrugadministrationroute062drugindicationMENOPAUSE

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application NumberNDA020538Brand NameVIVELLE-DOTGeneric NameESTRADIOLManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0343, 0078-0365, 0078-0344, 0078-0345, 0078-0346Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMALActive IngredientsESTRADIOLRXCUI241946, 242891, 242892, 248478, 284378, 310172, 310176, 310183, 1149632, 1149634spl_idf7a35df4-8f6a-4d7d-8249-220d3d36cb81spl_set_ide6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbfPackage NDC 0078-0365-62, 0078-0365-42, 0078-0365-45, 0078-0343-62, 0078-0343-42, 0078-0343- ... NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E

21)

drugcharacterization2medicinalproductBYSTOLICdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugadministrationroute048drugindicationHYPERTENSION

activesubstance

activesubstancenameNEBIVOLOL HYDROCHLORIDE

openFDA Info on Medication

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_id3f38e87f-c08a-4c22-8f31-b7d41f58b967spl_set_id8b8ad213-1dc8-454e-a524-075685c0e1a8Package NDC 0456-1402-30, 0456-1402-90, 0456-1402-01, 0456-1402-63, 0456-1405-30, 0456-1405- ... UNIIJGS34J7L9I

22)

drugcharacterization2medicinalproductAMOXICILLIN.drugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MG, QDdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

23)

drugcharacterization2medicinalproductATROVENTdrugstructuredosagenumb17drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext17 ?G, QDdrugindicationLUNG DISORDER

activesubstance

activesubstancenameIPRATROPIUM BROMIDE

openFDA Info on Medication

Application NumberNDA021527Brand NameATROVENT HFAGeneric NameIPRATROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0087Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsIPRATROPIUM BROMIDERXCUI836343, 836368spl_id694c27b3-b662-40bb-9cfd-bf7801fe8796spl_set_id170e98ef-5560-4068-be7d-e649068eb884Package NDC0597-0087-17UNIIJ697UZ2A9J

24)

drugcharacterization2medicinalproductNASONEXdrugstructuredosagenumb17drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext17 G, QDdrugindicationHYPERSENSITIVITY

activesubstance

activesubstancenameMOMETASONE FUROATE

25)

drugcharacterization2medicinalproductASMANEXdrugdosagetext1 PUFF, PRNdrugindicationLUNG DISORDER

activesubstance

activesubstancenameMOMETASONE FUROATE

openFDA Info on Medication

Application NumberNDA021067Brand NameASMANEXGeneric NameMOMETASONE FUROATEManufacturersOrganon LLCproduct_ndc78206-114, 78206-115Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsMOMETASONE FUROATERXCUI746803, 746804, 746810, 746811, 746812, 746813, 746814, 746815, 790283, 790284spl_id01be1fad-890f-4023-9c96-325bc50cda4dspl_set_id10b36fb2-6b0d-4f20-b197-3564d6f594b9Package NDC 78206-114-03, 78206-114-04, 78206-114-02, 78206-114-01, 78206-114-59, 78206-115- ... UNII04201GDN4R

summary

narrativeincludeclinicalCASE EVENT DATE: 2008