Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209176
Company: MITSUBISHI TANABE
Company: MITSUBISHI TANABE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RADICAVA | EDARAVONE | 30MG/100ML (0.3MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| RADICAVA | EDARAVONE | 60MG/100ML (0.6MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/05/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209176Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209176Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2019 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209176s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209176Orig1s009ltr.pdf | |
| 11/15/2018 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209176Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209176Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209176Orig1s007.pdf | |
| 08/17/2018 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/01/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209176s009lbl.pdf | |
| 11/01/2019 | SUPPL-9 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209176s009lbl.pdf | |
| 11/15/2018 | SUPPL-7 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209176Orig1s007lbl.pdf | |
| 05/05/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf |
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