← FDA DRUG APPROVALS

FDA NDA · NDA021623

SYNERA

Sponsor: GALEN SPECIALTY

APPLICATION
NDA021623
TYPE
NDA
ORIGINAL APPROVAL
2005-06-23
LATEST ACTION
2020-12-16
ROUTE
TOPICAL
DOSAGE FORM
PATCH
MARKETING STATUS
Discontinued

Products

SYNERA · ReferenceDiscontinued
LIDOCAINE 70MG, TETRACAINE 70MG · PATCH · TOPICAL

Approval history

2020-12-16Labeling · Supplement 25 · standard — Label ↗AP
2018-11-02Labeling · Supplement 24 · standard — Label ↗AP
2014-03-10Labeling · Supplement 17 · standard — Label ↗AP
2014-03-10Labeling · Supplement 15 · standard — Letter ↗AP
2014-01-10Manufacturing (CMC) · Supplement 23 · standardAP
2013-10-16Manufacturing (CMC) · Supplement 21 · standardAP
2013-07-09Manufacturing (CMC) · Supplement 22 · standardAP
2005-06-23Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →