Sildenafil Citrate

ANDA 202598, held by Chartwell Rx. Sildenafil Citrate.

As of Nov 15, 2026, ANDA 202598 (Sildenafil Citrate), held by Chartwell Rx, was first approved by FDA on Nov 6, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 6, 2012
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Adults Sildenafil tablets are 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 use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 6, 2012	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sildenafil CitrateEQ 20MG BASE · tablet;oral	Sildenafil Citrate	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 13, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jan 15, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Dec 10, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Nov 6, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 202598
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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