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FDA NDA · NDA021779

VENTAVIS

Sponsor: ACTELION

APPLICATION
NDA021779
TYPE
NDA
ORIGINAL APPROVAL
2004-12-29
LATEST ACTION
2022-03-02
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

VENTAVIS · ReferenceDiscontinued
ILOPROST 10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
VENTAVIS · ReferenceDiscontinued
ILOPROST 20MCG/ML (20MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION
VENTAVISDiscontinued
ILOPROST 20MCG/2ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INHALATION

Approval history

2022-03-02Labeling · Supplement 21 · standard — Letter ↗AP
2019-12-16Labeling · Supplement 19 · standard — Label ↗AP
2017-10-16Labeling · Supplement 18 · standard — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 16 · priorityAP
2014-11-10Manufacturing (CMC) · Supplement 15 · priorityAP
2013-11-25Labeling · Supplement 14 · standard — Label ↗AP
2012-04-26Labeling · Supplement 13 · unknown — Letter ↗AP
2011-02-08Labeling · Supplement 12 · unknown — Letter ↗AP
2010-04-20Labeling · Supplement 10 — Letter ↗AP
2009-08-07Manufacturing (CMC) · Supplement 9 — Label ↗AP
2008-09-22Labeling · Supplement 8 · standard — Label ↗AP
2008-03-04Labeling · Supplement 6 · standard — Letter ↗AP
2005-12-08Manufacturing (CMC) · Supplement 3 · priority — Letter ↗AP
2005-08-24Efficacy · Supplement 1 · standard — Label ↗AP
2005-08-24Manufacturing (CMC) · Supplement 2 · priority — Label ↗AP
2004-12-29Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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