Erygel

As of Nov 14, 2026, NDA 50617 (Erygel), held by Mylan, was first approved by FDA on Oct 21, 1987, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1987
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jun 30, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Oct 21, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Erygel2% · gel;topical	Erythromycin	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Dec 19, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 11, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 10, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 8, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 5, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 12, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Jan 3, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 30, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Mar 18, 1993	Supplement 2Labeling	Approved	None posted
Oct 21, 1987	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50617
Drugs@FDA: Overview at FDA
Company: Mylan

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