← FDA DRUG APPROVALS

FDA NDA · NDA207962

ZTLIDO

lidocaine

Sponsor: SCILEX PHARMS

APPLICATION
NDA207962
TYPE
NDA
ORIGINAL APPROVAL
2018-02-28
LATEST ACTION
2021-04-08
ROUTE
TOPICAL
DOSAGE FORM
PATCH
MARKETING STATUS
Prescription

Products

ZTLIDO · ReferencePrescription
LIDOCAINE 1.8% · PATCH · TOPICAL

Approval history

2021-04-08Efficacy · Supplement 5 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 1 · standard — Letter ↗AP
2018-02-28Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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