Altavera

ANDA 79102, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 79102 (Altavera), held by Xiromed, was first approved by FDA on Aug 3, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2010
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Altavera 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
Aug 3, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Altavera0.03MG;0.15MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Rx

All 7 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Mar 4, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Mar 3, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 8Labeling · Standard review	Approved	None posted
Feb 25, 2014	Supplement 6Labeling · Standard review	Approved	None posted
May 24, 2011	Supplement 2Labeling	Approved	None posted
Aug 3, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 79102
Drugs@FDA: Overview at FDA
Company: Xiromed

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