APPLICATION
ANDA062768
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-16
LATEST ACTION
2000-09-11
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEPHALEXINDiscontinued
CEPHALEXIN EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2000-09-11Manufacturing (CMC) · Supplement 21AP
1998-07-15Labeling · Supplement 18AP
1998-07-15Manufacturing (CMC) · Supplement 19AP
1997-08-20Manufacturing (CMC) · Supplement 17AP
1996-07-16Labeling · Supplement 16AP
1996-07-03Manufacturing (CMC) · Supplement 15AP
1995-05-04Manufacturing (CMC) · Supplement 13AP
1995-05-04Labeling · Supplement 12AP
1994-06-28Manufacturing (CMC) · Supplement 11AP
1993-12-07Labeling · Supplement 10AP
1993-08-13Labeling · Supplement 8AP
1993-06-04Manufacturing (CMC) · Supplement 9AP
1993-06-04Manufacturing (CMC) · Supplement 7AP
1992-07-30Labeling · Supplement 6AP
1992-03-24Manufacturing (CMC) · Supplement 4AP
1992-02-27Labeling · Supplement 5AP
1989-07-13Manufacturing (CMC) · Supplement 3AP
1987-06-16OriginalAP
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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