FDA NDA · NDA203109

REVATIO

sildenafil citrate

Sponsor: VIATRIS

APPLICATION

NDA203109

TYPE

NDA

ORIGINAL APPROVAL

2012-08-30

LATEST ACTION

2024-10-25

ROUTE

ORAL

DOSAGE FORM

FOR SUSPENSION

MARKETING STATUS

Discontinued

Products

REVATIO · ReferenceDiscontinued

SILDENAFIL CITRATE EQ 10MG BASE/ML · FOR SUSPENSION · ORAL

2024-10-25Manufacturing (CMC) · Supplement 19 — Letter ↗AP

2023-03-03Efficacy · Supplement 16 · standard — Letter ↗AP

2020-02-21Labeling · Supplement 15 · standard — Letter ↗AP

2019-01-17Labeling · Supplement 12 · standard — Label ↗AP

2017-07-31Labeling · Supplement 11 · standard — Label ↗AP

2016-11-22Manufacturing (CMC) · Supplement 10 · standardAP

2015-06-04Manufacturing (CMC) · Supplement 8 · priorityAP

2015-04-27Labeling · Supplement 9 · standard — Letter ↗AP

2015-01-12Manufacturing (CMC) · Supplement 7 · priorityAP

2014-03-11Labeling · Supplement 2 · standard — Label ↗AP

2014-03-06Labeling · Supplement 5 · standard — Label ↗AP

2014-01-31Labeling · Supplement 3 · standard — Label ↗AP

2014-01-31Efficacy · Supplement 4 · standard — Letter ↗AP

2012-08-30Type 3 - New Dosage Form · Original · priority — Summary Review ↗AP

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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