APPLICATION
ANDA062982
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-10
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 16 · standardAP
2015-09-25Labeling · Supplement 15 · standardAP
2001-01-26Manufacturing (CMC) · Supplement 9AP
1996-08-20Labeling · Supplement 8AP
1996-08-20Labeling · Supplement 7AP
1996-04-26Manufacturing (CMC) · Supplement 5AP
1994-06-01Labeling · Supplement 4AP
1994-06-01Manufacturing (CMC) · Supplement 3AP
1993-04-27Labeling · Supplement 1AP
1989-02-10OriginalAP
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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