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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 213298

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NDA 213298 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 213298

Tradename:	ROFLUMILAST
Applicant:	Aurobindo Pharma Ltd
Ingredient:	roflumilast
Patents:	0

Pharmacology for NDA: 213298

Mechanism of Action	Phosphodiesterase 4 Inhibitors

Suppliers and Packaging for NDA: 213298

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROFLUMILAST	roflumilast	TABLET;ORAL	213298	ANDA	Aurobindo Pharma Limited	59651-275	59651-275-30	30 TABLET in 1 BOTTLE (59651-275-30)
ROFLUMILAST	roflumilast	TABLET;ORAL	213298	ANDA	Aurobindo Pharma Limited	59651-275	59651-275-90	90 TABLET in 1 BOTTLE (59651-275-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MCG
Approval Date:	Apr 17, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MCG
Approval Date:	Jan 31, 2025	TE:	AB	RLD:	No

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