Estradiol And Norgestimate

ANDA 76812, held by Barr. Estradiol; Norgestimate.

As of Nov 15, 2026, ANDA 76812 (Estradiol And Norgestimate), held by Barr, was first approved by FDA on Apr 29, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 29, 2005
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 29, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estradiol And Norgestimate1MG,1MG;N/A,0.09MG · tablet;oral	Estradiol; Norgestimate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jan 29, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Feb 15, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Nov 3, 2017	Supplement 14Labeling · Standard review	Approved	None posted
Feb 26, 2007	Supplement 5Labeling	Approved	None posted
Apr 29, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76812
Drugs@FDA: Overview at FDA
Company: Barr 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