Revatio

NDA 21845, held by Viatris. Sildenafil Citrate.

As of Nov 14, 2026, NDA 21845 (Revatio), held by Viatris, was first approved by FDA on Jun 3, 2005, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 3, 2005
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Adults REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. Pediatric Patients (1 to 17 Years Old) REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jan 31, 2023	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jan 31, 2014	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 30, 2012	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 7, 2009	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 3, 2005	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
RevatioEQ 20MG BASE · tablet;oral	Sildenafil Citrate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Dec 16, 2024	Supplement 28Manufacturing	Approved	Label Letter
Jan 31, 2023	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 1, 2018	Supplement 18Labeling · Standard review	Approved	Label Letter
Jul 31, 2017	Supplement 20Labeling · Standard review	Approved	Label
Apr 27, 2015	Supplement 16Labeling · Standard review	Approved	Label Letter
Feb 3, 2015	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 11, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 6, 2014	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 31, 2014	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 31, 2014	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 30, 2012	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 19, 2010	Supplement 7Labeling	Approved	Label Letter
May 7, 2009	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 17, 2009	Supplement 5Labeling · Standard review	Approved	Label Letter
Dec 18, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Jul 27, 2006	Supplement 2Labeling · Standard review	Approved	Patient Information Sheet Letter
Jul 19, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Nov 3, 2005	Supplement 1Labeling · Standard review	Approved	Letter
Jun 3, 2005	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 21845
Drugs@FDA: Overview at FDA
Company: Viatris

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters