Levonorgestrel And Ethinyl Estradiol

ANDA 203872, held by Naari Pte. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 203872 (Levonorgestrel And Ethinyl Estradiol), held by Naari Pte, was first approved by FDA on Dec 22, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2015
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 22, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levonorgestrel And Ethinyl Estradiol0.03MG,0.01MG;0.15MG,N/A · tablet;oral	Ethinyl Estradiol; Levonorgestrel	Rx

All 3 submissions, including labeling and manufacturing supplements


Oct 4, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Oct 4, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Dec 22, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203872
Drugs@FDA: Overview at FDA
Company: Naari Pte Ltd

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