Skip to contentApplication 090253
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7074 | mycophenolate mofetil | mycophenolate mofetil | Major Pharmaceuticals | ANDA | Current |
| 0904-7074 | mycophenolate mofetil | mycophenolate mofetil | Major Pharmaceuticals | ANDA | Current |
| 16729-094 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 16729-094 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 16729-094 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 16729-094 | mycophenolate mofetil | mycophenolate mofetil | Accord Healthcare Inc. | ANDA | Current |
| 70518-2835 | mycophenolate mofetil | mycophenolate mofetil | REMEDYREPACK INC. | ANDA | Current |
| 70518-2835 | mycophenolate mofetil | mycophenolate mofetil | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44548 | ORIG | 2015-07-02 |
| 44417 | ORIG | 2009-07-15 |