APPLICATION
ANDA062816
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-28
LATEST ACTION
2000-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 125MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2000-12-08Manufacturing (CMC) · Supplement 22AP
1999-11-08Manufacturing (CMC) · Supplement 21AP
1997-12-29Manufacturing (CMC) · Supplement 20AP
1997-07-30Manufacturing (CMC) · Supplement 19AP
1996-04-17Manufacturing (CMC) · Supplement 18AP
1996-03-12Labeling · Supplement 17AP
1995-06-23Manufacturing (CMC) · Supplement 16AP
1995-01-27Manufacturing (CMC) · Supplement 15AP
1994-01-13Manufacturing (CMC) · Supplement 14AP
1993-11-19Manufacturing (CMC) · Supplement 13AP
1993-11-09Manufacturing (CMC) · Supplement 11AP
1993-11-09Manufacturing (CMC) · Supplement 12AP
1991-01-23Manufacturing (CMC) · Supplement 4AP
1990-12-26Labeling · Supplement 9AP
1988-12-07Manufacturing (CMC) · Supplement 3AP
1988-11-10Manufacturing (CMC) · Supplement 2AP
1988-11-08Manufacturing (CMC) · Supplement 1AP
1988-10-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.