Last Updated: May 10, 2026

Details for New Drug Application (NDA): 075582

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NDA 075582 describes DICLOFENAC POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Onesource Specialty, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Chartwell Rx, Ingenus Pharms Llc, Rk Pharma, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in eighteen NDAs. It is available from forty-four suppliers. Additional details are available on the DICLOFENAC POTASSIUM profile page.

The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for 075582

Tradename:	DICLOFENAC POTASSIUM
Applicant:	Chartwell Rx
Ingredient:	diclofenac potassium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 23, 2001	TE:		RLD:	No

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