Details for New Drug Application (NDA): 208213

NDA 208213 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 208213

Tradename:	ROFLUMILAST
Applicant:	Hetero Labs Ltd Iii
Ingredient:	roflumilast
Patents:	0

Pharmacology for NDA: 208213

Mechanism of Action

Phosphodiesterase 4 Inhibitors

Suppliers and Packaging for NDA: 208213

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROFLUMILAST	roflumilast	TABLET;ORAL	208213	ANDA	Camber Pharmaceuticals, Inc.	31722-623	31722-623-30	30 TABLET in 1 BOTTLE (31722-623-30)
ROFLUMILAST	roflumilast	TABLET;ORAL	208213	ANDA	Camber Pharmaceuticals, Inc.	31722-623	31722-623-32	100 BLISTER PACK in 1 CARTON (31722-623-32) / 10 TABLET in 1 BLISTER PACK (31722-623-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	Nov 23, 2018	TE:	AB	RLD:	No

Profile for product number 002

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

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