FDA.reportPublic FDA data

Application 206137

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;12.5MG;20MGNoNo
002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;12.5MG;40MGNoNo
003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 5MG BASE;25MG;40MGNoNo
004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;12.5MG;40MGNoNo
005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILTABLET;ORALEQ 10MG BASE;25MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-786olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-786olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-786olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-786olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-787olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-787olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-787olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-787olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-788olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-788olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-788olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-788olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-789olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-789olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-789olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-789olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-790olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-790olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-790olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-790olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
63629-2238olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2238olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2238olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2239olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2239olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2239olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2240olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2240olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2240olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2241olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2241olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-2241olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45767ORIG2016-11-01
45696ORIG2016-10-28