Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204410
Company: ACTELION PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPSUMIT MACITENTAN 10MG 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
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
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
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
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

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