APPLICATION
ANDA063024
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-12
LATEST ACTION
2025-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CEPHALEXINPrescription
CEPHALEXIN EQ 500MG BASE · TABLET · ORAL
CEPHALEXINPrescription
CEPHALEXIN EQ 250MG BASE · TABLET · ORAL
Approval history
2025-05-07Labeling · Supplement 32 · standardAP
2025-05-07Labeling · Supplement 30 · standardAP
2025-05-07Labeling · Supplement 33 · standardAP
2025-05-07Labeling · Supplement 31 · standardAP
2011-02-22Labeling · Supplement 26AP
2009-11-16Labeling · Supplement 25AP
2007-09-27Labeling · Supplement 21AP
2007-02-08Labeling · Supplement 20AP
2003-12-19Labeling · Supplement 17AP
2003-09-22Labeling · Supplement 16AP
2002-05-20Manufacturing (CMC) · Supplement 10AP
2001-10-24Manufacturing (CMC) · Supplement 12AP
2001-08-14Manufacturing (CMC) · Supplement 11AP
2000-07-07Manufacturing (CMC) · Supplement 9AP
2000-01-18Manufacturing (CMC) · Supplement 8AP
1998-07-21Manufacturing (CMC) · Supplement 7AP
1997-08-28Manufacturing (CMC) · Supplement 6AP
1996-10-04Manufacturing (CMC) · Supplement 5AP
1995-02-16Manufacturing (CMC) · Supplement 4AP
1994-09-06Manufacturing (CMC) · Supplement 3AP
1993-10-13Labeling · Supplement 2AP
1992-11-12Labeling · Supplement 1AP
1989-01-12OriginalAP
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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