FDA.reportPublic FDA data

Application 090654

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL25MG;50MGNoNo
002METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL25MG;100MGNoNo
003METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METOPROLOL TARTRATETABLET;ORAL50MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-368Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-368Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-369Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-369Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-370Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-370Metoprolol Tartrate and HydrochlorothiazideMetoprolol Tartrate and HydrochlorothiazideSun Pharmaceutical Industries, Inc.ANDACurrent