Iclevia

ANDA 206850, held by Aurobindo Pharma Ltd. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 206850 (Iclevia), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 29, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 29, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Iclevia TM (levonorgestrel and ethinyl estradiol tablets) 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 4 submissions below

Date	Submission	Status	Documents
Jun 29, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Iclevia0.03MG;0.15MG · tablet;oral	Ethinyl Estradiol; Levonorgestrel	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 24, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jun 24, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jun 24, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jun 29, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 206850
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