Application 211212
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SIROLIMUS | SIROLIMUS | SOLUTION;ORAL | 1MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-1594 | Sirolimus | SIrolimus | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1594 | Sirolimus | SIrolimus | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1594 | Sirolimus | SIrolimus | Amneal Pharmaceuticals NY LLC | ANDA | Current |