Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Diclofenac sodium

CompanyAlembic Pharmaceuticals Inc. (DUNS: 079288842)

Effective Date

January 10, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Diclofenac(20 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

62332-487

Application Number

ANDA212506

Marketing Category

ANDA (C73584)

Route of Administration

TOPICAL

Effective Date

January 10, 2024

Ingredients

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

DiclofenacActive

Code: QTG126297QClass: ACTIBQuantity: 20 mg in 1 g

HYDROXYPROPYL CELLULOSE (430000 WAMW)Inactive

Code: VQ8ZWO78F6Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

DIMETHYL SULFOXIDEInactive

Code: YOW8V9698HClass: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy