Suppliers and packages for generic ingredient: LEFLUNOMIDE
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LEFLUNOMIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905 | NDA | sanofi-aventis U.S. LLC | 0088-2160-30 | 1 BOTTLE in 1 CARTON (0088-2160-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1998-09-10 |
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905 | NDA | sanofi-aventis U.S. LLC | 0088-2161-30 | 1 BOTTLE in 1 CARTON (0088-2161-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1998-09-10 |
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905 | NDA | sanofi-aventis U.S. LLC | 0088-2162-33 | 1 BLISTER PACK in 1 CARTON (0088-2162-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1998-09-10 |
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905 | NDA AUTHORIZED GENERIC | Winthrop U.S. | 0955-1737-30 | 1 BOTTLE in 1 CARTON (0955-1737-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 2015-09-07 |
| Abhai Llc | LEFLUNOMIDE | leflunomide | TABLET;ORAL | 212453 | ANDA | KVK-Tech, Inc. | 10702-277-03 | 30 TABLET in 1 BOTTLE (10702-277-03) | 2020-07-23 |
| Abhai Llc | LEFLUNOMIDE | leflunomide | TABLET;ORAL | 212453 | ANDA | KVK-Tech, Inc. | 10702-278-03 | 30 TABLET in 1 BOTTLE (10702-278-03) | 2020-07-23 |
| Aet Pharma | LEFLUNOMIDE | leflunomide | TABLET;ORAL | 213497 | ANDA | Burel Pharmaceuticals, LLC | 35573-447-30 | 30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30) | 2022-01-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
