Combipatch

Treats moderate to severe vasomotor symptoms due to menopause. NDA 20870, held by Noven Pharms Inc. Estradiol; Norethindrone Acetate.

As of Nov 13, 2026, NDA 20870 (Combipatch), held by Noven Pharms Inc, was first approved by FDA on Aug 7, 1998, with 15 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1998
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE CombiPatch is indicated in a woman with a uterus for: Treatment of moderate to severe vasomotor symptoms due to menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Aug 7, 1998	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Products

2 strengths and forms


Combipatch0.05MG/24HR;0.14MG/24HR · film, extended release;transdermal	Estradiol; Norethindrone Acetate	RxReference drug
Combipatch0.05MG/24HR;0.25MG/24HR · film, extended release;transdermal	Estradiol; Norethindrone Acetate	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 33Labeling · Standard review	Approved	Letter Label
Nov 1, 2017	Supplement 23Labeling · Standard review	Approved	Label
Jun 8, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
May 7, 2015	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 19, 2013	Supplement 17Labeling	Approved	Label Letter
Nov 16, 2005	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 13, 2005	Supplement 13Labeling · Standard review	Approved	Label Letter
Jun 18, 2004	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 1, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 12, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 15, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
May 4, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 19, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 4, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 29, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 7, 1998	Original applicationNew dosage form · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 20870
Drugs@FDA: Overview at FDA
Company: Noven Pharmaceuticals

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