Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209223
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 90MG | TABLET;ORAL | Discontinued | None | No | No |
DEFERASIROX | DEFERASIROX | 360MG | TABLET;ORAL | Discontinued | None | No | No |
DEFERASIROX | DEFERASIROX | 180MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/24/2020 | ORIG-2 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209223Orig1s000ltr.pdf | |
11/25/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209223Orig1s000ltr.pdf |