← FDA DRUG APPROVALS

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

Approval history

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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →