Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213674
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XTANDI | ENZALUTAMIDE | 40MG | TABLET;ORAL | Prescription | None | Yes | No |
| XTANDI | ENZALUTAMIDE | 80MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/2020 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213674s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213674Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213674s010,203415s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213674Orig1s010; 203415Orig1s022ltr.pdf | |
| 09/09/2022 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s019,213674s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203415Orig1s019; 213674Orig1s006ltr.pdf | |
| 01/13/2022 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203415Orig1s018; 213674Orig1s005ltr.pdf | |
| 05/24/2021 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213674s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213674Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213674s010,203415s022lbl.pdf | |
| 09/09/2022 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s019,213674s006lbl.pdf | |
| 01/13/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf | |
| 01/13/2022 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203415s018,213674s005lbl.pdf | |
| 05/24/2021 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213674s002lbl.pdf | |
| 08/04/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213674s000lbl.pdf |