Application 077086
- Type
- ANDA
- Sponsor
- HERITAGE PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEFLUNOMIDE | LEFLUNOMIDE | TABLET;ORAL | 10MG | No | No |
| 002 | LEFLUNOMIDE | LEFLUNOMIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 23155-043 | Leflunomide | Leflunomide | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-043 | Leflunomide | Leflunomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-043 | leflunomide | leflunomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-044 | Leflunomide | Leflunomide | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-044 | Leflunomide | Leflunomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-044 | leflunomide | leflunomide | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 68258-2992 | Leflunomide | Leflunomide | Dispensing Solutions, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23858 | ORIG | 2010-08-09 |
| 31195 | ORIG | 2005-09-15 |