FDA NDA · NDA022473

REVATIO

sildenafil citrate

Sponsor: VIATRIS

APPLICATION

NDA022473

TYPE

NDA

ORIGINAL APPROVAL

2009-11-18

LATEST ACTION

2024-12-16

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

REVATIO · ReferencePrescription

SILDENAFIL CITRATE EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) · SOLUTION · INTRAVENOUS

2024-12-16Manufacturing (CMC) · Supplement 19 — Label ↗AP

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

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

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

2015-04-27Labeling · Supplement 10 · standard — Label ↗AP

2014-08-21Manufacturing (CMC) · Supplement 8 · standardAP

2014-03-11Labeling · Supplement 4 · standard — Label ↗AP

2014-03-06Labeling · Supplement 7 · standard — Label ↗AP

2014-01-31Efficacy · Supplement 6 · standard — Label ↗AP

2014-01-31Labeling · Supplement 5 · standard — Letter ↗AP

2012-08-30Efficacy · Supplement 3 · standard — Letter ↗AP

2010-11-19Labeling · Supplement 1 · unknown — Label ↗AP

2009-11-18Type 3 - New Dosage Form · Original · standard — Label ↗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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