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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211819

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NDA 211819 describes APREMILAST, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Macleods Pharms Ltd, Mankind Pharma, MSN, Shilpa, Teva Pharms Usa Inc, Torrent, and Unichem, and is included in thirteen NDAs. It is available from one supplier. Additional details are available on the APREMILAST profile page.

The generic ingredient in APREMILAST is apremilast. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apremilast profile page.

Summary for 211819

Tradename:	APREMILAST
Applicant:	Unichem
Ingredient:	apremilast
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 17, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Feb 17, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Feb 17, 2021	TE:		RLD:	No

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