Myzilra

ANDA 77502, held by Ph Health. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 77502 (Myzilra), held by Ph Health, was first approved by FDA on Nov 23, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 23, 2011
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 23, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Myzilra0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Aug 4, 2014	Supplement 4Manufacturing	Approved	None posted
Nov 23, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77502
Drugs@FDA: Overview at FDA
Company: PH Health

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