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, and Unichem, and is included in twelve 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.
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 Action | Phosphodiesterase 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: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 30, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 30, 2021 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jun 30, 2021 | TE: | RLD: | No | |||||
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