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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 217010

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NDA 217010 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, Novast Labs, 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-five 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-nine suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for 217010

Tradename:	DICLOFENAC POTASSIUM
Applicant:	Umedica
Ingredient:	diclofenac potassium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	50MG
Approval Date:	Aug 29, 2025	TE:	AB	RLD:	No

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