Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021779
Company: ACTELION PHARMS LTD
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 Prescription None Yes Yes
VENTAVIS ILOPROST 20MCG/ML (20MCG/ML) SOLUTION;INHALATION 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
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
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-Container/Carton Labels, Labeling-Package Insert 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
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021779s009lbl.pdf
08/07/2009 SUPPL-9 Labeling-Package Insert 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

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