Setlakin

ANDA 90716, held by Novast Labs. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 90716 (Setlakin), held by Novast Labs, was first approved by FDA on Sep 15, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 15, 2014
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SETLAKIN 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
Sep 15, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Setlakin0.03MG;0.15MG · tablet;oral	Ethinyl Estradiol; Levonorgestrel	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 17, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Jun 17, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Jun 17, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Sep 15, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 90716
Drugs@FDA: Overview at FDA
Company: Novast Laboratories

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