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FDA ANDA · ANDA065310
AMPICILLIN AND SULBACTAM
ampicillin sodium and sulbactam sodium
Sponsor: SANDOZ
APPLICATION
ANDA065310
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-25
LATEST ACTION
2026-01-30
ROUTE
INTRAVENOUS, 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
2026-01-30Labeling · Supplement 30 · standardAP
2024-08-22Labeling · Supplement 28 · standardAP
2021-07-06Labeling · Supplement 24 · standardAP
2020-04-29Labeling · Supplement 19 · standardAP
2020-04-29Labeling · Supplement 21 · standardAP
2015-02-12Labeling · Supplement 15 · standardAP
2015-02-12Labeling · Supplement 13 · standardAP
2007-10-31Manufacturing (CMC) · Supplement 2AP
2006-07-25OriginalAP
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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