Viorele

ANDA 91346, held by Glenmark Pharms Ltd. Desogestrel; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 91346 (Viorele), held by Glenmark Pharms Ltd, was first approved by FDA on Apr 2, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 2, 2012
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 2, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Viorele0.15MG,N/A;0.02MG,0.01MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Rx

All 8 submissions, including labeling and manufacturing supplements


Apr 25, 2024	Supplement 16Manufacturing	Approved	None posted
Aug 25, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Aug 25, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Apr 13, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Mar 28, 2013	Supplement 1Labeling · Standard review	Approved	None posted
Apr 2, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91346
Drugs@FDA: Overview at FDA
Company: Glenmark 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