Application 207373
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESTOSTERONE | TESTOSTERONE | GEL, METERED;TRANSDERMAL | 1.62% (20.25MG/1.25GM ACTUATION) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-1013 | Testosterone | Testosterone | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1013 | Testosterone | Testosterone | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1013 | Testosterone | Testosterone | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1013 | Testosterone | Testosterone | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1013 | Testosterone | Testosterone | Amneal Pharmaceuticals NY LLC | ANDA | Current |