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FDA Approval

Alfuzosin Hydrochloride

CompanyDenton Pharma, Inc. DBA Northwind Pharmaceuticals (DUNS: 080355546)

Effective Date

November 23, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Alfuzosin(10 mg in 1 1)

Registrants (1)

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

DUNS Number

080355546

Manufacturing Establishments (1)

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Labeler

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Registrant

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

DUNS Number

080355546

Products (1)

Alfuzosin Hydrochloride

NDC Product Code

70934-306

Application Number

ANDA079057

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 23, 2021

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive

Code: 905HNO1SIHClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

AlfuzosinActive

Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1

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