Levonorgestrel

ANDA 78665, held by Fdn Consumer. Levonorgestrel.

As of Nov 13, 2026, ANDA 78665 (Levonorgestrel), held by Fdn Consumer, was first approved by FDA on Aug 28, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2009
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
Aug 28, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levonorgestrel0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levonorgestrel	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 26, 2012	Supplement 5Labeling	Approved	None posted
Sep 1, 2010	Supplement 1Labeling	Approved	None posted
Aug 28, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78665
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