FDA.reportPublic FDA data

Application 204832

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;50MGNoNo
002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;100MGNoNo
003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL25MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-190losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-190losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-190losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-190losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-191losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-191losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-191losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-191losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-192losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-192losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-192losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-192losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
71610-671losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49086ORIG2017-07-26