Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209426
Company: TORRENT
Company: TORRENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/05/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209426Orig1s000TAltr.pdf |