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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 208272

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NDA 208272 describes ROFLUMILAST, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Micro Labs, MSN, Pharmobedient, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in eleven NDAs. It is available from fourteen suppliers. Additional details are available on the ROFLUMILAST profile page.

The generic ingredient in ROFLUMILAST is roflumilast. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

Summary for 208272

Tradename:	ROFLUMILAST
Applicant:	Torrent
Ingredient:	roflumilast
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	Aug 6, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MCG
Approval Date:	Oct 18, 2024	TE:		RLD:	No

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