Details for New Drug Application (NDA): 209677
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NDA 209677 describes TERIFLUNOMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Glenmark Pharms, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty-one 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-two 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-two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209677
| Tradename: | TERIFLUNOMIDE |
| Applicant: | Sola Pharms |
| Ingredient: | teriflunomide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209677
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 209677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209677 | ANDA | SOLA Pharmaceuticals, LLC | 70512-850 | 70512-850-28 | 1 BLISTER PACK in 1 CARTON (70512-850-28) / 28 TABLET, COATED in 1 BLISTER PACK |
| TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209677 | ANDA | SOLA Pharmaceuticals, LLC | 70512-851 | 70512-851-28 | 1 BLISTER PACK in 1 CARTON (70512-851-28) / 28 TABLET, COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 14MG | ||||
| Approval Date: | Jun 17, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
| Approval Date: | Sep 28, 2023 | TE: | AB | RLD: | No | ||||
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