Drugs@FDA: FDA-Approved Drugs
New Drug Application:
Company:
Company:
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/08/2014 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/12/2024 | SUPPL-31 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 09/12/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/13/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/17/2023 | SUPPL-27 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/08/2023 | SUPPL-26 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/30/2021 | SUPPL-24 | Efficacy-New Indication |
Label is not available on this site. |
||
| 02/03/2020 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2020 | SUPPL-20 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/18/2019 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/26/2018 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/22/2019 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 10/20/2017 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 03/01/2017 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/17/2016 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/14/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2015 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 07/31/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/12/2024 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf | |
| 09/12/2023 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf | |
| 05/08/2023 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf | |
| 02/17/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf | |
| 02/17/2023 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf | |
| 10/13/2022 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202293s028lbl.pdf | |
| 04/30/2021 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf | |
| 05/05/2020 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf | |
| 02/03/2020 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf | |
| 02/03/2020 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf | |
| 01/24/2020 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.pdf | |
| 10/18/2019 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf | |
| 02/22/2019 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s015lbl.pdf | |
| 10/26/2018 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf | |
| 10/20/2017 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf | |
| 03/01/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf | |
| 03/01/2017 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf | |
| 08/17/2016 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf | |
| 08/17/2016 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf | |
| 06/14/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf | |
| 12/04/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf | |
| 03/11/2015 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf | |
| 08/08/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf | |
| 01/08/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf |