Ayuna

ANDA 206866, held by Aurobindo Pharma. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 206866 (Ayuna), held by Aurobindo Pharma, was first approved by FDA on Sep 23, 2016, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 23, 2016
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ayuna is indicated for use by females of reproductive potential to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 23, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ayuna0.03MG;0.15MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Rx

All 7 submissions, including labeling and manufacturing supplements


Feb 3, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Apr 22, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Jan 12, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Jan 12, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Sep 23, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206866
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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