Last Updated: September 25, 2026

Details for New Drug Application (NDA): 208272

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

The generic ingredient in ROFLUMILAST is roflumilast. There is one drug master file entry for this compound. Seventeen 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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