Enskyce

Prevents pregnancy. ANDA 201887, held by Lupin Ltd. Desogestrel; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 201887 (Enskyce), held by Lupin Ltd, was first approved by FDA on Mar 7, 2013, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 7, 2013
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Enskyce Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Enskyce, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 7, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Enskyce0.15MG;0.03MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Rx

All 10 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Nov 15, 2019	Supplement 15Manufacturing	Approved	None posted
May 23, 2019	Supplement 13Manufacturing	Approved	None posted
May 23, 2019	Supplement 10Labeling · Standard review	Approved	None posted
May 23, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Jun 2, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Jun 19, 2015	Supplement 3Manufacturing	Approved	None posted
Apr 1, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Mar 7, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 201887
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