Introvale

ANDA 79064, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 79064 (Introvale), held by Xiromed, was first approved by FDA on Sep 27, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2010
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Introvale (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Introvale is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 27, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Introvale0.03MG;0.15MG · tablet;oral	Ethinyl Estradiol; Levonorgestrel	Rx

All 6 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Jun 25, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jun 25, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Jun 25, 2026	Supplement 11Labeling · Standard review	Approved	None posted
May 18, 2011	Supplement 2Labeling	Approved	None posted
Sep 27, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 79064
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