Last Updated: September 25, 2026

Details for New Drug Application (NDA): 208299

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NDA 208299 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 208299

Tradename:	ROFLUMILAST
Applicant:	Prinston Inc
Ingredient:	roflumilast
Patents:	0

Pharmacology for NDA: 208299

Mechanism of Action	Phosphodiesterase 4 Inhibitors

Suppliers and Packaging for NDA: 208299

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROFLUMILAST	roflumilast	TABLET;ORAL	208299	ANDA	Solco Healthcare US, LLC.	43547-005	43547-005-03	30 TABLET in 1 BOTTLE (43547-005-03)
ROFLUMILAST	roflumilast	TABLET;ORAL	208299	ANDA	Solco Healthcare US, LLC.	43547-005	43547-005-09	90 TABLET in 1 BOTTLE (43547-005-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	May 10, 2022	TE:	AB	RLD:	No

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