APPLICATION
ANDA062994
TYPE
ANDA
ORIGINAL APPROVAL
1988-09-15
LATEST ACTION
2000-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2000-12-08Manufacturing (CMC) · Supplement 19AP
1999-11-08Manufacturing (CMC) · Supplement 18AP
1997-12-29Manufacturing (CMC) · Supplement 17AP
1997-12-11Labeling · Supplement 15AP
1997-07-30Manufacturing (CMC) · Supplement 14AP
1996-04-17Manufacturing (CMC) · Supplement 13AP
1996-03-12Labeling · Supplement 11AP
1995-06-23Manufacturing (CMC) · Supplement 12AP
1995-01-27Manufacturing (CMC) · Supplement 10AP
1994-03-22Labeling · Supplement 4AP
1994-01-13Manufacturing (CMC) · Supplement 9AP
1993-11-19Manufacturing (CMC) · Supplement 7AP
1991-01-23Manufacturing (CMC) · Supplement 5AP
1988-12-07Manufacturing (CMC) · Supplement 2AP
1988-11-08Manufacturing (CMC) · Supplement 1AP
1988-09-15OriginalAP
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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