Application 210519
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 125MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 250MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-549 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-549 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-549 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-550 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-550 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-550 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-551 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-551 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
| 67877-551 | Deferasirox | Deferasirox | Ascend Laboratories, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61214 | ORIG | 2019-12-10 |