APPLICATION
ANDA062738
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-19
LATEST ACTION
2024-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 2GM BASE/VIAL · POWDER · INTRAVENOUS
AMPICILLIN SODIUMDiscontinued
AMPICILLIN SODIUM EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS
Approval history
2024-05-01Labeling · Supplement 33 · standardAP
2020-02-20Labeling · Supplement 24 · standardAP
2013-07-31Labeling · Supplement 17AP
2007-03-19Labeling · Supplement 10AP
2004-10-04Labeling · Supplement 5AP
2001-12-04Manufacturing (CMC) · Supplement 4AP
1996-03-26Manufacturing (CMC) · Supplement 3AP
1992-10-30Manufacturing (CMC) · Supplement 2AP
1990-07-24Manufacturing (CMC) · Supplement 1AP
1987-02-19OriginalAP
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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