Details for New Drug Application (NDA): 213497
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NDA 213497 describes LEFLUNOMIDE, which is a drug marketed by Abhai Llc, Aet Pharma, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Barr, Heritage Pharms, Lupin Ltd, Sandoz, Teva Pharms, Wanbang Biopharms, and Zydus Lifesciences, and is included in twelve NDAs. It is available from sixteen suppliers. Additional details are available on the LEFLUNOMIDE profile page.
The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.
Summary for 213497
| Tradename: | LEFLUNOMIDE |
| Applicant: | Aet Pharma |
| Ingredient: | leflunomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213497
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213497 | ANDA | Burel Pharmaceuticals, LLC | 35573-447 | 35573-447-30 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30) |
| LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213497 | ANDA | Burel Pharmaceuticals, LLC | 35573-448 | 35573-448-30 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-448-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 10, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 10, 2021 | TE: | AB | RLD: | No | ||||
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