Cyclessa

NDA 21090, held by Aspen Global Inc. Desogestrel; Ethinyl Estradiol.

As of Nov 14, 2026, NDA 21090 (Cyclessa), held by Aspen Global Inc, was first approved by FDA on Dec 20, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2000
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 20, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyclessa0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 9Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 10, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 26, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Feb 24, 2004	Supplement 3Labeling · Standard review	Approved	Letter
Mar 8, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 27, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 21090
Drugs@FDA: Overview at FDA
Company: Aspen Global Inc

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