Application 200197
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | CAPSULE;ORAL | 250MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67877-266 | mycophenolate mofetil | mycophenolate mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-266 | mycophenolate mofetil | mycophenolate mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-266 | mycophenolate mofetil | mycophenolate mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-266 | mycophenolate mofetil | mycophenolate mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-266 | mycophenolate mofetil | mycophenolate mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-266 | mycophenolate mofetil | mycophenolate mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 70518-3068 | mycophenolate mofetil | mycophenolate mofetil | REMEDYREPACK INC. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 44569 | ORIG | 2015-07-02 |