Levonorgestrel And Ethinyl Estradiol

ANDA 200490, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 200490 (Levonorgestrel And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on Apr 21, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 21, 2015
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Introvale 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 5 submissions below

Date	Submission	Status	Documents
Apr 21, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levonorgestrel And Ethinyl Estradiol0.03MG;0.15MG · tablet;oral	Ethinyl Estradiol; Levonorgestrel	Rx

All 5 submissions, including labeling and manufacturing supplements


Nov 18, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Nov 18, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Feb 28, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Feb 28, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Apr 21, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 200490
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