Details for New Drug Application (NDA): 209613
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NDA 209613 describes TERIFLUNOMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Glenmark Speclt, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in eighteen NDAs. It is available from twenty suppliers. Additional details are available on the TERIFLUNOMIDE profile page.
The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209613
| Tradename: | TERIFLUNOMIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | teriflunomide |
| Patents: | 0 |
Pharmacology for NDA: 209613
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209613
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209613 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1303 | 69238-1303-2 | 2 BLISTER PACK in 1 CARTON (69238-1303-2) / 14 TABLET, FILM COATED in 1 BLISTER PACK |
| TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209613 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1303 | 69238-1303-6 | 28 TABLET, FILM COATED in 1 BOTTLE (69238-1303-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
| Approval Date: | Sep 28, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
| Approval Date: | Sep 28, 2018 | TE: | RLD: | No | |||||
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