Seasonale

NDA 21544, held by Teva Branded Pharm. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, NDA 21544 (Seasonale), held by Teva Branded Pharm, was first approved by FDA on Sep 5, 2003, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 5, 2003
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JOLESSA is indicated for use by females of reproductive potential to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 5, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Seasonale0.03MG;0.15MG · tablet;oral	Ethinyl Estradiol; Levonorgestrel	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Jan 27, 2023	Supplement 15Labeling · Standard review	Approved	Label Letter
Jan 27, 2023	Supplement 14Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 17Labeling · Standard review	Approved	Label
Aug 9, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Mar 31, 2017	Supplement 10Labeling · Standard review	Approved	Letter Label
Mar 31, 2017	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 5, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 5, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21544
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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