APPLICATION
ANDA064082
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-29
LATEST ACTION
2025-09-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued
Products
AMPICILLIN TRIHYDRATEPrescription
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE · CAPSULE · ORAL
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2025-09-02Labeling · Supplement 23 · standardAP
2024-05-01Labeling · Supplement 22 · standardAP
2020-12-22Labeling · Supplement 15 · standardAP
2004-09-30Labeling · Supplement 8AP
1997-04-07Manufacturing (CMC) · Supplement 4AP
1996-11-04Manufacturing (CMC) · Supplement 3AP
1996-11-04Manufacturing (CMC) · Supplement 1AP
1996-11-04Manufacturing (CMC) · Supplement 2AP
1995-08-29OriginalAP
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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