Application 065416
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-019 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 16729-019 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 16729-019 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 16729-019 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 50090-2541 | mycophenolate mofetil | mycophenolate mofetil | A-S Medication Solutions | ANDA | Current |
| 50090-2541 | mycophenolate mofetil | mycophenolate mofetil | A-S Medication Solutions | ANDA | Current |
| 63629-9582 | mycophenolate mofetil | mycophenolate mofetil | Bryant Ranch Prepack | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 24042 | ORIG | 2015-07-06 |
| 44239 | ORIG | 2009-07-15 |