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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
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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