Synera

NDA 21623, held by Galen Specialty. Lidocaine; Tetracaine.

As of Nov 15, 2026, NDA 21623 (Synera), held by Galen Specialty, was first approved by FDA on Jun 23, 2005, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2005
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 23, 2005	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Synera70MG;70MG · patch;topical	Lidocaine; Tetracaine	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Dec 16, 2020	Supplement 25Labeling · Standard review	Approved	Letter Label
Nov 2, 2018	Supplement 24Labeling · Standard review	Approved	Letter Label
Mar 10, 2014	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 10, 2014	Supplement 17Labeling · Standard review	Approved	Letter Label
Jan 10, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 16, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 9, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 23, 2005	Original applicationNew combination · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21623
Drugs@FDA: Overview at FDA
Company: Galen Specialty

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