Levonorgestrel

ANDA 202334, held by Perrigo R And D. Levonorgestrel.

As of Nov 13, 2026, ANDA 202334 (Levonorgestrel), held by Perrigo R And D, was first approved by FDA on Aug 20, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 20, 2014
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
Aug 20, 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
Feb 27, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Feb 27, 2023	Supplement 7Labeling · Standard review	Approved	None posted
May 12, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Aug 20, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202334
Drugs@FDA: Overview at FDA
Company: Perrigo R&D

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