Orsythia

ANDA 77099, held by Ph Health. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 77099 (Orsythia), held by Ph Health, was first approved by FDA on May 11, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: May 11, 2011
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 11, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Orsythia0.02MG;0.1MG · tablet;oral-28	Ethinyl Estradiol; Levonorgestrel	Discontinued

All 5 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
Apr 30, 2014	Supplement 5Manufacturing	Approved	None posted
Jan 3, 2012	Supplement 1Manufacturing	Approved	None posted
May 11, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77099
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