Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211774

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NDA 211774 describes APREMILAST, which is a drug marketed by Alkem Labs Ltd, Amneal, Annora, Aurobindo Pharma Ltd, Dr Reddys, Glenmark Pharms Ltd, Macleods Pharms, Mankind Pharma, MSN, Shilpa, Teva Pharms Usa Inc, Torrent, and Unichem, and is included in thirteen NDAs. Additional details are available on the APREMILAST profile page.

The generic ingredient in APREMILAST is apremilast. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.

Summary for 211774

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 7, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 7, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Apr 7, 2023	TE:	AB	RLD:	No

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