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FDA Approval

Diclofenac Sodium

CompanyAlembic Pharmaceuticals Inc. (DUNS: 079288842)

Effective Date

March 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Diclofenac(30 mg in 1 g)

Registrants (1)

Alembic Pharmaceuticals Limited

DUNS Number

650574663

Manufacturing Establishments (1)

Alembic Pharmaceuticals Limited

Labeler

Alembic Pharmaceuticals Inc.

Registrant

Alembic Pharmaceuticals Limited

DUNS Number

871411532

Products (1)

Diclofenac Sodium

NDC Product Code

62332-581

Application Number

ANDA212351

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

March 1, 2023

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBHClass: IACT

DiclofenacActive

Code: QTG126297QClass: ACTIBQuantity: 30 mg in 1 g

HYALURONATE SODIUMInactive

Code: YSE9PPT4THClass: IACT

PEG-7 METHYL ETHERInactive

Code: ENK4Y6S66XClass: IACT

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