Sildenafil Citrate

ANDA 210394, held by Ajanta Pharma Ltd. Sildenafil Citrate.

As of Nov 15, 2026, ANDA 210394 (Sildenafil Citrate), held by Ajanta Pharma Ltd, was first approved by FDA on May 4, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: May 4, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Adults Sildenafil tablets, USP 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 3 submissions below

Date	Submission	Status	Documents
May 4, 2018	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Mar 24, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Mar 24, 2025	Supplement 25Labeling · Standard review	Approved	None posted
May 4, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210394
Drugs@FDA: Overview at FDA
Company: Ajanta Pharma

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