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FDA NDA · NDA021496

DUOCAINE

Sponsor: AMPHASTAR PHARMS INC

APPLICATION
NDA021496
TYPE
NDA
ORIGINAL APPROVAL
2003-05-23
LATEST ACTION
2003-05-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DUOCAINEDiscontinued
BUPIVACAINE HYDROCHLORIDE EQ 0.375% (37.5MG/10ML), LIDOCAINE HYDROCHLORIDE EQ 1% (100MG/10ML) · INJECTABLE · INJECTION

Approval history

2003-05-23Type 4 - New Combination · Original · standardReviewAP
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