APPLICATION
ANDA062883
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-25
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 15 · standardAP
2019-11-22Labeling · Supplement 14 · standardAP
1997-07-22Labeling · Supplement 8AP
1994-07-01Labeling · Supplement 7AP
1994-03-31Manufacturing (CMC) · Supplement 6AP
1994-03-31Manufacturing (CMC) · Supplement 5AP
1994-01-31Manufacturing (CMC) · Supplement 4AP
1993-04-01Labeling · Supplement 3AP
1991-11-20Manufacturing (CMC) · Supplement 1AP
1991-11-20Manufacturing (CMC) · Supplement 2AP
1988-02-25OriginalAP
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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