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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 200158

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NDA 200158 describes DICLOFENAC SODIUM AND MISOPROSTOL, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the DICLOFENAC SODIUM AND MISOPROSTOL profile page.

The generic ingredient in DICLOFENAC SODIUM AND MISOPROSTOL 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 200158

Tradename:	DICLOFENAC SODIUM AND MISOPROSTOL
Applicant:	Sandoz
Ingredient:	diclofenac sodium; misoprostol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	50MG;0.2MG
Approval Date:	May 9, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	75MG;0.2MG
Approval Date:	May 9, 2013	TE:		RLD:	No

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