← FDA DRUG APPROVALS

FDA NDA · NDA021717

PLIAGLIS

lidocaine and tetracaine

Sponsor: CRESCITA THERAP

APPLICATION
NDA021717
TYPE
NDA
ORIGINAL APPROVAL
2006-06-29
LATEST ACTION
2018-12-11
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

PLIAGLIS · ReferencePrescription
LIDOCAINE 7%, TETRACAINE 7% · CREAM · TOPICAL

Approval history

2018-12-11Labeling · Supplement 10 · standard — Label ↗AP
2018-11-02Labeling · Supplement 11 · standard — Label ↗AP
2017-11-21Labeling · Supplement 9 · standard — Label ↗AP
2015-03-09Manufacturing (CMC) · Supplement 7 · standardAP
2013-11-07Labeling · Supplement 5 · standard — Letter ↗AP
2007-06-28Labeling · Supplement 2 · standard — Letter ↗AP
2006-06-29Type 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.

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