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FDA ANDA · ANDA065074

AMPICILLIN AND SULBACTAM

Sponsor: HIKMA

APPLICATION
ANDA065074
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-19
LATEST ACTION
2009-01-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMPICILLIN AND SULBACTAMDiscontinued
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN AND SULBACTAMDiscontinued
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2009-01-15Labeling · Supplement 22AP
2004-01-02Labeling · Supplement 10AP
2002-03-19OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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