Details for New Drug Application (NDA): 077086
✉ Email this page to a colleague
NDA 077086 describes LEFLUNOMIDE, which is a drug marketed by Abhai Llc, Aet Pharma, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Barr, Heritage, 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 077086
| Tradename: | LEFLUNOMIDE |
| Applicant: | Heritage |
| Ingredient: | leflunomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEFLUNOMIDE | leflunomide | TABLET;ORAL | 077086 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-043 | 23155-043-03 | 30 TABLET in 1 BOTTLE (23155-043-03) |
| LEFLUNOMIDE | leflunomide | TABLET;ORAL | 077086 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-043 | 23155-043-05 | 500 TABLET in 1 BOTTLE (23155-043-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 13, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Sep 13, 2005 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
