Levonorgestrel

ANDA 202739, held by Xiromed. Levonorgestrel.

As of Nov 13, 2026, ANDA 202739 (Levonorgestrel), held by Xiromed, was first approved by FDA on Oct 31, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2014
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 31, 2014	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
Jul 31, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 20, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Oct 31, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202739
Drugs@FDA: Overview at FDA
Company: Xiromed

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