Application 212087
- Type
- ANDA
- Sponsor
- CONCORD BIOTECH 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 |
|---|
| 68254-5003 | Mycophenolate Mofetil | mycophenolate mofetil | CONCORD BIOTECH LIMITED | ANDA | Current |
| 68254-5003 | MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | CONCORD BIOTECH LIMITED | ANDA | Current |
| 68254-5003 | Mycophenolate Mofetil | mycophenolate mofetil | CONCORD BIOTECH LIMITED | ANDA | Current |
| 70748-262 | Mycophenolate Mofetil | mycophenolate mofetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70748-262 | Mycophenolate Mofetil | mycophenolate mofetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 70748-262 | Mycophenolate Mofetil | mycophenolate mofetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76496 | ORIG | 2023-11-07 |