Bekyree

ANDA 202226, held by Lupin. Desogestrel; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 202226 (Bekyree), held by Lupin, was first approved by FDA on Aug 12, 2015, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 12, 2015
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 12, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bekyree0.15MG,N/A;0.02MG,0.01MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Rx

All 7 submissions, including labeling and manufacturing supplements


Mar 3, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Mar 3, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Mar 30, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Mar 30, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 3Labeling · Standard review	Approved	None posted
Aug 12, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202226
Drugs@FDA: Overview at FDA
Company: Lupin

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