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FDA ANDA · ANDA201024

AMPICILLIN SODIUM AND SULBACTAM SODIUM

ampicillin sodium, sulbactam sodium

Sponsor: ONESOURCE SPECIALTY

APPLICATION
ANDA201024
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-07
LATEST ACTION
2020-04-19
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2020-04-19Labeling · Supplement 3 · standardAP
2020-04-19Labeling · Supplement 4 · standardAP
2016-02-17Labeling · Supplement 1 · standardAP
2014-04-07Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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