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Last Updated: January 5, 2025

Details for New Drug Application (NDA): 212490

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NDA 212490 describes ROFLUMILAST, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Torrent, and Zydus Pharms, and is included in eleven NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

Summary for 212490

Tradename:	ROFLUMILAST
Applicant:	Alkem Labs Ltd
Ingredient:	roflumilast
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MCG
Approval Date:	Apr 18, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	Apr 18, 2023	TE:	AB	RLD:	No

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