Sildenafil Citrate

ANDA 202025, held by Amneal Pharms. Sildenafil Citrate.

As of Nov 15, 2026, ANDA 202025 (Sildenafil Citrate), held by Amneal Pharms, was first approved by FDA on Feb 28, 2013, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2013
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Feb 28, 2013	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Jan 15, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jan 15, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Feb 28, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202025
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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