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FDA NDA · NDA022466

ORABLOC

articaine hydrochloride and epinephrine bitartrate

Sponsor: PIERREL

APPLICATION
NDA022466
TYPE
NDA
ORIGINAL APPROVAL
2010-02-26
LATEST ACTION
2025-07-02
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ORABLOC · ReferencePrescription
ARTICAINE HYDROCHLORIDE 4%, EPINEPHRINE BITARTRATE EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) · INJECTABLE · INJECTION
ORABLOC · ReferencePrescription
ARTICAINE HYDROCHLORIDE 4%, EPINEPHRINE BITARTRATE EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2025-07-02Labeling · Supplement 9 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 5 · standard — Label ↗AP
2014-03-10Manufacturing (CMC) · Supplement 2 · standardAP
2011-01-20Labeling · Supplement 1 · unknown — Label ↗AP
2010-02-26Type 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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