APPLICATION
ANDA062901
TYPE
ANDA
ORIGINAL APPROVAL
1988-11-25
LATEST ACTION
2018-05-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
UNASYNDiscontinued
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
UNASYNDiscontinued
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2018-05-01Labeling · Supplement 29 · standardAP
2015-09-10Labeling · Supplement 28 · standardAP
2015-09-10Labeling · Supplement 27 · standardAP
2008-10-02Labeling · Supplement 20AP
2005-06-02Labeling · Supplement 16AP
2002-04-09Manufacturing (CMC) · Supplement 15AP
2001-02-16Manufacturing (CMC) · Supplement 13AP
2001-02-16Manufacturing (CMC) · Supplement 12AP
1998-05-19Manufacturing (CMC) · Supplement 11AP
1997-05-08Manufacturing (CMC) · Supplement 8AP
1997-01-10Manufacturing (CMC) · Supplement 10AP
1996-05-29Manufacturing (CMC) · Supplement 9AP
1992-10-30Manufacturing (CMC) · Supplement 6AP
1992-03-31Manufacturing (CMC) · Supplement 1AP
1992-03-31Manufacturing (CMC) · Supplement 4AP
1992-02-27Labeling · Supplement 2AP
1988-11-25OriginalAP
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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