Skip to contentApplication 091249
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-4275 | Mycophenolate Mofetil | Mycophenolate Mofetil | A-S Medication Solutions | ANDA | Current |
| 50090-4275 | Mycophenolate Mofetil | Mycophenolate Mofetil | A-S Medication Solutions | ANDA | Current |
| 50090-4275 | Mycophenolate Mofetil | Mycophenolate Mofetil | A-S Medication Solutions | ANDA | Current |
| 50090-4275 | Mycophenolate Mofetil | Mycophenolate Mofetil | A-S Medication Solutions | ANDA | Current |
| 67877-225 | Mycophenolate Mofetil | Mycophenolate Mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-225 | Mycophenolate Mofetil | Mycophenolate Mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-225 | Mycophenolate Mofetil | Mycophenolate Mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-225 | Mycophenolate Mofetil | Mycophenolate Mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-225 | Mycophenolate Mofetil | Mycophenolate Mofetil | Ascend Laboratories, LLC | ANDA | Current |
| 67877-225 | Mycophenolate Mofetil | Mycophenolate Mofetil | Ascend Laboratories, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44555 | ORIG | 2015-07-06 |