Enpresse-21, Enpresse-28

ANDA 75809, held by Duramed Pharms Barr. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 75809 (Enpresse-21, Enpresse-28), held by Duramed Pharms Barr, was first approved by FDA on Jul 16, 2001, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2001
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 16, 2001	Original application	Approved	None posted

Products

2 strengths and forms


Enpresse-210.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG · tablet;oral-21	Ethinyl Estradiol; Levonorgestrel	Discontinued
Enpresse-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Rx

All 8 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 31Labeling · Standard review	Approved	None posted
Jan 28, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Jan 28, 2022	Supplement 27Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 24Labeling · Standard review	Approved	None posted
Jun 19, 2002	Supplement 4Manufacturing	Approved	None posted
May 21, 2002	Supplement 3Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 2Manufacturing	Approved	None posted
Jul 16, 2001	Original application	Approved	None posted

Identifiers

Application: ANDA 75809
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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