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FDA Approval

Alfuzosin Hydrochloride

CompanyCipla USA Inc. (DUNS: 078719707)

Effective Date

October 1, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Alfuzosin(10 mg in 1 1)

Registrants (1)

DUNS Number

078719707

Manufacturing Establishments (1)

InvaGen Pharmaceutical Inc

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

080334903

Products (1)

Alfuzosin Hydrochloride extended release

NDC Product Code

69097-844

Application Number

ANDA090284

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 28, 2020

Ingredients

AlfuzosinActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

GUAR GUMInactive

Code: E89I1637KEClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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