Fempatch

NDA 20417, held by Parke Davis. Estradiol.

As of Nov 15, 2026, NDA 20417 (Fempatch), held by Parke Davis, was first approved by FDA on Dec 3, 1996, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1996
Review: Standard
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 3, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fempatch0.025MG/24HR · film, extended release;transdermal	Estradiol	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 17, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Dec 18, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 3, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20417
Drugs@FDA: Overview at FDA
Company: Parke-Davis

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