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FDA ANDA · ANDA090339
AMPICILLIN AND SULBACTAM
ampicillin sodium and sulbactam sodium
Sponsor: EUGIA PHARMA SPECLTS
APPLICATION
ANDA090339
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-20
LATEST ACTION
2024-08-02
ROUTE
INTRAVENOUS, 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
2024-08-02Labeling · Supplement 14 · standardAP
2022-10-12Labeling · Supplement 13 · standardAP
2020-04-19Labeling · Supplement 8 · standardAP
2020-04-19Labeling · Supplement 9 · standardAP
2015-04-06Labeling · Supplement 4 · standardAP
2015-04-06Labeling · Supplement 2 · standardAP
2010-09-20OriginalAP
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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