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FDA ANDA · ANDA078959

CITANEST FORTE DENTAL

prilocaine hcl and epinephrine

Sponsor: SEPTODONT INC

APPLICATION
ANDA078959
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-30
LATEST ACTION
2019-11-26
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPrescription
EPINEPHRINE BITARTRATE 0.005MG/ML, PRILOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION

Approval history

2019-11-26Labeling · Supplement 6 · standardAP
2011-08-30OriginalAP
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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