APPLICATION
ANDA065076
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-19
LATEST ACTION
2009-01-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 10GM BASE/VIAL, SULBACTAM SODIUM EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2009-01-21Labeling · Supplement 24AP
2006-03-08Labeling · Supplement 21AP
2004-03-26Labeling · Supplement 11AP
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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