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FDA ANDA · ANDA077250

MARCAINE

bupivacaine hydrochloride and epinephrine bitartrate

Sponsor: SEPTODONT

APPLICATION
ANDA077250
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-27
LATEST ACTION
2015-08-27
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VIVACAINEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5%, EPINEPHRINE BITARTRATE 0.0091MG/ML · INJECTABLE · INJECTION

Approval history

2015-08-27Labeling · Supplement 10 · standardAP
2013-03-28Labeling · Supplement 9 · standardAP
2007-11-29Labeling · Supplement 2AP
2007-01-30Labeling · Supplement 1AP
2006-09-27OriginalAP
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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