APPLICATION
ANDA062797
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-12
LATEST ACTION
2024-05-01
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 125MG BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN SODIUMPrescription
AMPICILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-05-01Labeling · Supplement 13 · standardAP
2018-02-15Labeling · Supplement 8 · standardAP
2018-02-15Labeling · Supplement 6 · standardAP
2018-02-15Labeling · Supplement 7 · standardAP
2004-06-25Labeling · Supplement 1AP
1993-07-12OriginalAP
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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