Sildenafil Citrate

Treats erectile dysfunction. ANDA 77342, held by Teva. Sildenafil Citrate.

As of Nov 15, 2026, ANDA 77342 (Sildenafil Citrate), held by Teva, was first approved by FDA on Mar 9, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 9, 2016
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sildenafil tablets are indicated for the treatment of erectile dysfunction.

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
Mar 9, 2016	Original application	Approved	Letter

Products

3 strengths and forms


Sildenafil CitrateEQ 25MG BASE · tablet;oral	Sildenafil Citrate	Rx
Sildenafil CitrateEQ 50MG BASE · tablet;oral	Sildenafil Citrate	Rx
Sildenafil CitrateEQ 100MG BASE · tablet;oral	Sildenafil Citrate	Rx

All 4 submissions, including labeling and manufacturing supplements


Dec 12, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Dec 12, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Dec 12, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Mar 9, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 77342
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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