Last Updated: August 3, 2026

Details for New Drug Application (NDA): 217646

✉ Email this page to a colleague

« Back to Dashboard

NDA 217646 describes DICLOFENAC SODIUM, which is a drug marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Sun Pharma Canada, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon Research, Sandoz, Sciegen Pharms, Apotex, Epic Pharma Llc, Lupin, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Umedica, Unique, Dexcel Ltd, Ingenus Pharms Llc, Vpna, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-five NDAs. It is available from one hundred and twenty-two suppliers. Additional details are available on the DICLOFENAC SODIUM profile page.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

Summary for 217646

Tradename:	DICLOFENAC SODIUM
Applicant:	Encube
Ingredient:	diclofenac sodium
Patents:	0

Pharmacology for NDA: 217646

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 217646

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	217646	ANDA	Encube Ethicals, Inc.	21922-033	21922-033-16	1 BOTTLE, PUMP in 1 CARTON (21922-033-16) / 112 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	2%
Approval Date:	Apr 9, 2025	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.