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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 020809

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NDA 020809 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 Inc, Apotex, Epic Pharma Llc, Lupin Ltd, 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, Novast Labs, 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-six 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 020809

Tradename:	DICLOFENAC SODIUM
Applicant:	Falcon Pharms
Ingredient:	diclofenac sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.1%
Approval Date:	May 4, 1998	TE:		RLD:	No

Expired US Patents for NDA 020809

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Falcon Pharms	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020809-001	May 4, 1998	5,603,929	⤷ Get Started Free
Falcon Pharms	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020809-001	May 4, 1998	5,653,972	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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