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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211782


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NDA 211782 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 211782
Tradename:APREMILAST
Applicant:Amneal
Ingredient:apremilast
Patents:0
Pharmacology for NDA: 211782
Mechanism of ActionPhosphodiesterase 4 Inhibitors
Suppliers and Packaging for NDA: 211782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APREMILAST apremilast TABLET;ORAL 211782 ANDA Amneal Pharmaceuticals NY LLC 60219-1410 60219-1410-6 60 TABLET, FILM COATED in 1 BOTTLE (60219-1410-6)
APREMILAST apremilast TABLET;ORAL 211782 ANDA Amneal Pharmaceuticals NY LLC 60219-1744 60219-1744-7 1 KIT in 1 KIT (60219-1744-7) * 4 TABLET, FILM COATED in 1 BLISTER PACK * 19 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jun 30, 2021TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Jun 30, 2021TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength30MG
Approval Date:Jun 30, 2021TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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