Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204410
Company: ACTELION
Company: ACTELION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPSUMIT | MACITENTAN | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/18/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204410s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204410Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/11/2024 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204410Orig1s027ltr.pdf |
| 05/26/2023 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204410s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204410Orig1s024ltr.pdf | |
| 02/01/2023 | SUPPL-23 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204410Orig1s023ltr.pdf |
| 10/25/2021 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204410s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204410Orig1s022ltr.pdf | |
| 05/26/2021 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204410s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204410Orig1s021ltr.pdf | |
| 04/08/2020 | SUPPL-20 | REMS - MODIFIED - D-N-A, REMS - MODIFIED - BIFURCATED |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204410Orig1s020ltr.pdf |
| 06/10/2019 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 02/01/2019 | SUPPL-18 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204410Orig1s018ltr.pdf |
| 04/23/2019 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204410s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204410Orig1s017ltr.pdf | |
| 08/25/2017 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204410Orig1s013ltr.pdf |
| 03/21/2017 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204410Orig1s011ltr.pdf | |
| 10/16/2018 | SUPPL-10 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204410s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204410Orig1s010ltr.pdf | |
| 10/21/2016 | SUPPL-9 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s009ltr.pdf |
| 06/15/2016 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s008ltr.pdf | |
| 02/22/2016 | SUPPL-7 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s007ltr.pdf |
| 02/17/2016 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s006ltr.pdf | |
| 03/22/2016 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2015 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s003ltr.pdf | |
| 11/17/2015 | SUPPL-2 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s002ltr.pdf | |
| 05/20/2014 | 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 |
|---|---|---|---|---|---|
| 05/26/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204410s024lbl.pdf | |
| 10/25/2021 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204410s022lbl.pdf | |
| 05/26/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204410s021lbl.pdf | |
| 04/23/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204410s017lbl.pdf | |
| 10/16/2018 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204410s010lbl.pdf | |
| 03/21/2017 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf | |
| 03/21/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf | |
| 06/15/2016 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s008lbl.pdf | |
| 02/17/2016 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s006lbl.pdf | |
| 11/17/2015 | SUPPL-2 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s002lbl.pdf | |
| 04/30/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s003lbl.pdf | |
| 10/18/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204410s000lbl.pdf |
OPSUMIT
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OPSUMIT | MACITENTAN | 10MG | TABLET;ORAL | Prescription | Yes | AB | 204410 | ACTELION |