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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 208236

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NDA 208236 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 are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.

Summary for 208236

Tradename:	ROFLUMILAST
Applicant:	Senores Pharms
Ingredient:	roflumilast
Patents:	0

Pharmacology for NDA: 208236

Mechanism of Action	Phosphodiesterase 4 Inhibitors

Suppliers and Packaging for NDA: 208236

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROFLUMILAST	roflumilast	TABLET;ORAL	208236	ANDA	Jubilant Cadista Pharmaceuticals Inc.	59746-801	59746-801-70	28 TABLET in 1 BLISTER PACK (59746-801-70)
ROFLUMILAST	roflumilast	TABLET;ORAL	208236	ANDA	Jubilant Cadista Pharmaceuticals Inc.	59746-802	59746-802-05	500 TABLET in 1 BOTTLE (59746-802-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	Oct 3, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MCG
Approval Date:	Oct 19, 2023	TE:		RLD:	No

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