Application 211374
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | INJECTABLE;INJECTION | 500MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70121-1584 | mycophenolate mofetil | mycophenolate mofetil | Amneal Pharmaceuticals LLC | ANDA | Current |
| 70121-1584 | mycophenolate mofetil | mycophenolate mofetil | Amneal Pharmaceuticals LLC | ANDA | Current |
| 70121-1584 | mycophenolate mofetil | mycophenolate mofetil | Amneal Pharmaceuticals LLC | ANDA | Current |
| 70121-1584 | mycophenolate mofetil | mycophenolate mofetil | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76500 | ORIG | 2023-11-07 |