Levonorgestrel

ANDA 207044, held by Glenmark Pharms Ltd. Levonorgestrel.

As of Nov 13, 2026, ANDA 207044 (Levonorgestrel), held by Glenmark Pharms Ltd, was first approved by FDA on Mar 25, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

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
Mar 25, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levonorgestrel1.5MG · tablet;oral	Levonorgestrel	OTC

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 31, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Oct 31, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Oct 31, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Mar 25, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207044
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