Application 214289
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID | TABLET, DELAYED RELEASE;ORAL | 180MG | No | No |
| 002 | MYCOPHENOLIC ACID | MYCOPHENOLIC ACID | TABLET, DELAYED RELEASE;ORAL | 360MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24979-160 | mycophenolic acid | mycophenolic acid | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-160 | mycophenolic acid | mycophenolic acid | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-161 | mycophenolic acid | mycophenolic acid | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-161 | mycophenolic acid | mycophenolic acid | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 72789-246 | mycophenolic acid | mycophenolic acid | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-247 | mycophenolic acid | mycophenolic acid | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76503 | ORIG | 2023-11-07 |