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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021779
Company: ACTELION

Products on NDA 021779

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021779

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-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

Labels for NDA 021779

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-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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