Levonorgestrel

ANDA 200670, held by Fdn Consumer. Levonorgestrel.

As of Nov 13, 2026, ANDA 200670 (Levonorgestrel), held by Fdn Consumer, was first approved by FDA on Jul 12, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2012
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 12, 2012	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 19, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Mar 11, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Jul 12, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200670
Drugs@FDA: Overview at FDA
Company: FDN Consumer

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