APPLICATION
ANDA062745
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-01
LATEST ACTION
1992-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KEFLETDiscontinued
CEPHALEXIN EQ 500MG BASE · TABLET · ORAL
KEFLETDiscontinued
CEPHALEXIN EQ 250MG BASE · TABLET · ORAL
Approval history
1992-02-05Labeling · Supplement 3AP
1992-02-05Labeling · Supplement 2AP
1986-12-01OriginalAP
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.