Ashlyna

ANDA 203163, held by Glenmark Pharms Ltd. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 203163 (Ashlyna), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 23, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 23, 2015
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ashlynais indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen,

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
Feb 23, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ashlyna0.03MG,0.01MG;0.15MG,N/A · tablet;oral	Ethinyl Estradiol; Levonorgestrel	Rx

All 4 submissions, including labeling and manufacturing supplements


Jul 31, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Jan 13, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Feb 23, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203163
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