← FDA DRUG APPROVALS

FDA NDA · NDA020612

LIDOCAINE

Sponsor: TEIKOKU PHARMA USA

APPLICATION
NDA020612
TYPE
NDA
ORIGINAL APPROVAL
1999-03-19
LATEST ACTION
2018-11-02
ROUTE
CUTANEOUS, TOPICAL
DOSAGE FORM
PATCH
MARKETING STATUS
Prescription

Products

LIDODERM · ReferencePrescription
LIDOCAINE 5% · PATCH · TOPICAL

Approval history

2018-11-02Labeling · Supplement 14 · standard — Label ↗AP
2016-03-17Manufacturing (CMC) · Supplement 13 · standardAP
2015-01-07Labeling · Supplement 12 · standard — Label ↗AP
2010-04-13Labeling · Supplement 11 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 8 · standard — Label ↗AP
2005-05-05Labeling · Supplement 7 · standard — Letter ↗AP
2002-07-02Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1999-05-26Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1999-03-19Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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