Estrasorb

NDA 21371, held by Exeltis USA Inc. Estradiol Hemihydrate.

As of Nov 14, 2026, NDA 21371 (Estrasorb), held by Exeltis USA Inc, was first approved by FDA on Oct 9, 2003, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 9, 2003
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 9, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Estrasorb0.25% · emulsion;topical	Estradiol Hemihydrate	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Sep 10, 2024	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 15, 2024	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 1, 2017	Supplement 8Labeling · Standard review	Approved	Label
Mar 10, 2015	Supplement 7Labeling · Standard review	Approved	Letter Label
Oct 9, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21371
Drugs@FDA: Overview at FDA
Company: Exeltis USA 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