APPLICATION
ANDA063099
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-20
LATEST ACTION
2002-05-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TRIMOXDiscontinued
AMOXICILLIN 500MG · CAPSULE · ORAL
TRIMOXDiscontinued
AMOXICILLIN 250MG · CAPSULE · ORAL
Approval history
2002-05-08Manufacturing (CMC) · Supplement 2AP
1999-02-18Labeling · Supplement 1AP
1992-03-20OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.