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Last Updated: December 16, 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, 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 212490

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

Pharmacology for NDA: 212490

Mechanism of Action	Phosphodiesterase 4 Inhibitors

Suppliers and Packaging for NDA: 212490

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROFLUMILAST	roflumilast	TABLET;ORAL	212490	ANDA	Golden State Medical Supply, Inc.	51407-975	51407-975-90	90 TABLET in 1 BOTTLE (51407-975-90)
ROFLUMILAST	roflumilast	TABLET;ORAL	212490	ANDA	Ascend Laboratories, LLC	67877-480	67877-480-05	500 TABLET in 1 BOTTLE (67877-480-05)

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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