Cerinta

ANDA 202817, held by Sun Pharm. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 202817 (Cerinta), held by Sun Pharm, was first approved by FDA on Jan 7, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 7, 2019
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 7, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cerinta0.02MG;0.1MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Jan 7, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 202817
Drugs@FDA: Overview at FDA
Company: Sun 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