Kimidess

ANDA 76681, held by Ph Health. Desogestrel; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 76681 (Kimidess), held by Ph Health, was first approved by FDA on Apr 30, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2015
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
Apr 30, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kimidess0.15MG,N/A;0.02MG,0.01MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Apr 30, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 76681
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