Psorcon

NDA 20205, held by Taro Pharms North. Diflorasone Diacetate.

As of Nov 13, 2026, NDA 20205 (Psorcon), held by Taro Pharms North, was first approved by FDA on Nov 20, 1992, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 20, 1992
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
Nov 20, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Psorcon0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Diflorasone Diacetate	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 30, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 10, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 20, 1992	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20205
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals North America

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