APPLICATION
ANDA061502
TYPE
ANDA
ORIGINAL APPROVAL
1971-11-09
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE · CAPSULE · ORAL
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 140 · standardAP
2024-04-24Labeling · Supplement 138 · standardAP
2024-04-24Labeling · Supplement 139 · standardAP
2000-07-07Manufacturing (CMC) · Supplement 137AP
1997-12-10Manufacturing (CMC) · Supplement 136AP
1996-08-27Manufacturing (CMC) · Supplement 135AP
1991-11-05Labeling · Supplement 134AP
1971-11-09OriginalAP
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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