Application 209677
- Type
- ANDA
- Sponsor
- IMPAX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERIFLUNOMIDE | TERIFLUNOMIDE | TABLET;ORAL | 14MG | No | No |
| 002 | TERIFLUNOMIDE | TERIFLUNOMIDE | TABLET;ORAL | 7MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1565 | Teriflunomide | Teriflunomide | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73403 | ORIG | 2023-02-08 |