FDA.reportPublic FDA data

Application 076792

Type
ANDA
Sponsor
MYLAN

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
0378-0424Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0424Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0424Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0424Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0434Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0434Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0434Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0434Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0445Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0445Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0445Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent
0378-0445Metoprolol Tartrate and Hydrochlorothiazidemetoprolol tartrate and hydrochlorothiazideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8962ORIG2004-08-25