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FDA ANDA · ANDA079138

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Sponsor: HOSPIRA

APPLICATION
ANDA079138
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-18
LATEST ACTION
2013-02-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDiscontinued
ARTICAINE HYDROCHLORIDE 4%, EPINEPHRINE BITARTRATE EQ 0.017MG BASE/1.7ML (4% · INJECTABLE · INJECTION

Approval history

2013-02-28Labeling · Supplement 1AP
2010-06-18OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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