Sildenafil Citrate

ANDA 201150, held by Mylan Pharms Inc. Sildenafil Citrate.

As of Nov 15, 2026, ANDA 201150 (Sildenafil Citrate), held by Mylan Pharms Inc, was first approved by FDA on Nov 9, 2012, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2012
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 9, 2012	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Jun 13, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Apr 2, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Apr 2, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Apr 2, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Apr 2, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 9, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201150
Drugs@FDA: Overview at FDA
Company: Mylan 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