Levonorgestrel

ANDA 202508, held by Novel Labs Inc. Levonorgestrel.

As of Nov 13, 2026, ANDA 202508 (Levonorgestrel), held by Novel Labs Inc, was first approved by FDA on Feb 22, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 22, 2013
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indications 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
Feb 22, 2013	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
Jun 3, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Mar 19, 2014	Supplement 1Labeling	Approved	None posted
Mar 19, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Feb 22, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202508
Drugs@FDA: Overview at FDA
Company: Novel Laboratories

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