← FDA DRUG APPROVALS

FDA NDA · NDA019941

EMLA

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA019941
TYPE
NDA
ORIGINAL APPROVAL
1992-12-30
LATEST ACTION
2018-11-02
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

EMLA · ReferenceDiscontinued
LIDOCAINE 2.5%, PRILOCAINE 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2018-11-02Labeling · Supplement 21 · standard — Label ↗AP
2013-01-25Manufacturing (CMC) · Supplement 20 · standardAP
2006-04-27Labeling · Supplement 18 · standard — Label ↗AP
2005-12-19Labeling · Supplement 17 · standard — Review ↗AP
2003-01-27Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2000-06-02Manufacturing (CMC) · Supplement 13 · standardAP
2000-04-20Labeling · Supplement 12 · standard — Review ↗AP
2000-01-28Efficacy · Supplement 11 · standard — Review ↗AP
1999-03-11Efficacy · Supplement 10 · standard — Letter ↗AP
1998-02-04Labeling · Supplement 9 · standard — Review ↗AP
1998-02-04Labeling · Supplement 7 · standard — Review ↗AP
1998-02-04Efficacy · Supplement 8 · unknown — Review ↗AP
1996-05-31Manufacturing (CMC) · Supplement 5 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 6 · standardAP
1995-09-27Manufacturing (CMC) · Supplement 3 · standardAP
1994-04-11Labeling · Supplement 2 · standard — Review ↗AP
1992-12-30Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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