Details for New Drug Application (NDA): 209555
NDA 209555 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, Natco, Neocubes Pharma, Sandoz, Sola Pharms, Somerset Theraps Llc, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen NDAs. It is available from sixteen suppliers. Additional details are available on the TERIFLUNOMIDE profile page.
The generic ingredient in TERIFLUNOMIDE is teriflunomide. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
The generic ingredient in TERIFLUNOMIDE is teriflunomide. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209555
| Tradename: | TERIFLUNOMIDE |
| Applicant: | Natco |
| Ingredient: | teriflunomide |
| Patents: | 0 |
Pharmacology for NDA: 209555
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209555
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209555 | ANDA | Natco Pharma USA LLC | 69339-169 | 69339-169-03 | 30 TABLET in 1 BOTTLE (69339-169-03) |
| TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209555 | ANDA | Natco Pharma USA LLC | 69339-169 | 69339-169-09 | 90 TABLET in 1 BOTTLE (69339-169-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
| Approval Date: | May 15, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
| Approval Date: | May 15, 2023 | TE: | AB | RLD: | No | ||||
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