Cyclafem 0.5/35

ANDA 203413, held by Ph Health. Ethinyl Estradiol; Norethindrone.

As of Nov 15, 2026, ANDA 203413 (Cyclafem 0.5/35), held by Ph Health, was first approved by FDA on Dec 16, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 16, 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
Dec 16, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyclafem 0.5/350.035MG;0.5MG · tablet;oral-28	Ethinyl Estradiol; Norethindrone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Feb 8, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Dec 16, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203413
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