Application 204851
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLTESTOSTERONE | METHYLTESTOSTERONE | CAPSULE;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1408 | MethylTESTOSTERone | METHYLTESTOSTERONE | Impax Generics | ANDA | Current |
| 0115-1408 | MethylTESTOSTERone | METHYLTESTOSTERONE | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1408 | MethylTESTOSTERone | METHYLTESTOSTERONE | Amneal Pharmaceuticals of New York LLC | ANDA | Current |