FDA.reportPublic FDA data

Application 070265

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLDOPA AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METHYLDOPATABLET;ORAL25MG;250MGNoYes
002METHYLDOPA AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METHYLDOPATABLET;ORAL15MG;250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0507Methyldopa and Hydrochlorothiazidemethyldopa and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0507Methyldopa and Hydrochlorothiazidemethyldopa and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0711Methyldopa and Hydrochlorothiazidemethyldopa and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0711Methyldopa and Hydrochlorothiazidemethyldopa and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent