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FDA Approval

Alfuzosin hydrochloride

CompanyExelan Pharmaceuticals Inc. (DUNS: 967795266)

Effective Date

November 30, 2022

Labeling Type

Human Prescription Drug Label

Active Ingredients

Alfuzosin(10 mg in 1 1)

Registrants (1)

InvaGen Pharmaceuticals, Inc

DUNS Number

165104469

Manufacturing Establishments (1)

InvaGen Pharmaceuticals, Inc

Labeler

Exelan Pharmaceuticals Inc.

Registrant

InvaGen Pharmaceuticals, Inc

DUNS Number

080334903

Products (1)

Alfuzosin hydrochloride

NDC Product Code

76282-302

Application Number

ANDA090284

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 1, 2022

Ingredients

AlfuzosinActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GUAR GUMInactive

Code: E89I1637KEClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

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