Athentia Next

ANDA 206867, held by Aurobindo Pharma. Levonorgestrel.

As of Nov 13, 2026, ANDA 206867 (Athentia Next), held by Aurobindo Pharma, was first approved by FDA on Dec 8, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 8, 2015
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 8, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Athentia Next1.5MG · tablet;oral	Levonorgestrel	OTC

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 26, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Nov 30, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Aug 23, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Dec 8, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 206867
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