APPLICATION
ANDA062778
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-06
LATEST ACTION
1999-12-21
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEPHALEXINDiscontinued
CEPHALEXIN EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
1999-12-21Manufacturing (CMC) · Supplement 16AP
1999-05-20Manufacturing (CMC) · Supplement 15AP
1998-12-01Manufacturing (CMC) · Supplement 14AP
1997-04-01Labeling · Supplement 13AP
1995-01-27Manufacturing (CMC) · Supplement 12AP
1994-12-23Manufacturing (CMC) · Supplement 11AP
1993-10-15Labeling · Supplement 10AP
1992-06-23Manufacturing (CMC) · Supplement 6AP
1992-04-03Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 7AP
1989-03-08Manufacturing (CMC) · Supplement 5AP
1987-08-06OriginalAP
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.