Aviane-28, Aviane-21

Prevents pregnancy. ANDA 75796, held by Duramed Pharms Barr. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 75796 (Aviane-28, Aviane-21), held by Duramed Pharms Barr, was first approved by FDA on Apr 30, 2001, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2001
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Aviane (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 30, 2001	Original application	Approved	Letter Review Label

Products

2 strengths and forms


Aviane-280.02MG;0.1MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Rx
Aviane-210.02MG;0.1MG · tablet;oral-21	Ethinyl Estradiol; Levonorgestrel	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Feb 17, 2022	Supplement 24Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 22Labeling · Standard review	Approved	None posted
Mar 30, 2010	Supplement 17Labeling	Approved	None posted
Jun 19, 2002	Supplement 5Manufacturing	Approved	None posted
May 15, 2002	Supplement 4Manufacturing	Approved	None posted
May 3, 2002	Supplement 3Manufacturing	Approved	None posted
Oct 31, 2001	Supplement 1Manufacturing	Approved	None posted
Apr 30, 2001	Original application	Approved	Letter Review Label

Identifiers

Application: ANDA 75796
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