Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021779
Company: ACTELION
Company: ACTELION
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VENTAVIS | ILOPROST | 20MCG/2ML (10MCG/ML) | SOLUTION;INHALATION | Discontinued | None | No | No |
VENTAVIS | ILOPROST | 10MCG/ML (10MCG/ML) | SOLUTION;INHALATION | Discontinued | None | Yes | No |
VENTAVIS | ILOPROST | 20MCG/ML (20MCG/ML) | SOLUTION;INHALATION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021779lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021779ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-779_Ventavis.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/02/2022 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021779s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021779Orig1s021ltr.pdf | |
12/16/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021779s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021779Orig1s019ltr.pdf | |
10/16/2017 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021779s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021779Orig1s018ltr.pdf | |
01/05/2015 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/10/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/25/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021779s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021779Orig1s014ltr_corrected.pdf | |
04/26/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021779s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021779Orig1s013ltr.pdf | |
02/08/2011 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021779s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021779s012ltr.pdf | |
04/20/2010 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021779s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021779s010ltr.pdf | |
08/07/2009 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021779s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021779Orig1s009.pdf | |
09/22/2008 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s008ltr.pdf | |
03/04/2008 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021779s006ltr.pdf | |
12/08/2005 | SUPPL-3 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s003ltr.pdf | |
08/24/2005 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf | |
08/24/2005 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021779s001,002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/02/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021779s021lbl.pdf | |
12/16/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021779s019lbl.pdf | |
10/16/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021779s018lbl.pdf | |
11/25/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021779s014lbl.pdf | |
04/26/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021779s013lbl.pdf | |
02/08/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021779s012lbl.pdf | |
04/20/2010 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021779s010lbl.pdf | |
08/07/2009 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf | |
08/07/2009 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf | |
09/22/2008 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s008lbl.pdf | |
03/04/2008 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021779s006lbl.pdf | |
12/08/2005 | SUPPL-3 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s003lbl.pdf |
08/24/2005 | SUPPL-2 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf | |
08/24/2005 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021779s001,002lbl.pdf | |
12/29/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021779lbl.pdf |