← FDA DRUG APPROVALS

FDA NDA · NDA021451

ORAQIX

lidocaine and prilocaine

Sponsor: DENTSPLY PHARM

APPLICATION
NDA021451
TYPE
NDA
ORIGINAL APPROVAL
2003-12-19
LATEST ACTION
2022-03-02
ROUTE
PERIODONTAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

ORAQIX · ReferencePrescription
LIDOCAINE 2.5%, PRILOCAINE 2.5% · GEL · PERIODONTAL

Approval history

2022-03-02Labeling · Supplement 13 · standardAP
2018-11-02Labeling · Supplement 14 · standard — Label ↗AP
2012-08-08Labeling · Supplement 8 · standard — Letter ↗AP
2010-09-27Labeling · Supplement 7 · standard — Label ↗AP
2010-04-13Labeling · Supplement 5 · standard — Letter ↗AP
2003-12-19Type 4 - New Combination · 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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