FDA.reportPublic FDA data

Application 078020

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;80MGNoNo
002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;160MGNoNo
003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;160MGNoNo
004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;320MGNoNo
005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals IncANDACurrent
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6321Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals IncANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6322Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6323Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals IncANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals IncANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6324Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals IncANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-6325Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
50090-5985Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazideA-S Medication SolutionsANDACurrent
68788-7887Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7887Valsartan and Hydrochlorothiazidevalsartan and hydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9108ORIG2012-09-24