Psorcon E

NDA 17994, held by Pfizer. Diflorasone Diacetate.

As of Nov 13, 2026, NDA 17994 (Psorcon E), held by Pfizer, was first approved by FDA on Mar 1, 1978, with 22 approved supplements and 0 published complete response letters.

First approved: Mar 1, 1978
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Mar 1, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Psorcon E0.05% · ointment;topical	Diflorasone Diacetate	Discontinued

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 25, 2017	Supplement 26Labeling · Standard review	Approved	Letter Label
May 30, 2003	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 21, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 10, 1997	Supplement 20Manufacturing · Standard review	Approved	None posted
May 3, 1988	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 3, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
May 31, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 29, 1984	Supplement 16Labeling	Approved	None posted
Nov 4, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 20, 1982	Supplement 13Labeling	Approved	None posted
Aug 20, 1982	Supplement 14Labeling	Approved	None posted
Jun 25, 1981	Supplement 11Labeling	Approved	None posted
May 5, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 18, 1981	Supplement 9Labeling	Approved	None posted
Jan 16, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 17, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 16, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 16, 1979	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 16, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
May 22, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 10, 1979	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 7, 1978	Supplement 2Labeling	Approved	None posted
Mar 1, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17994
Drugs@FDA: Overview at FDA
Company: Pfizer

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