APPLICATION
ANDA062118
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-27
LATEST ACTION
2002-08-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CEPHALEXINDiscontinued
CEPHALEXIN EQ 250MG BASE · CAPSULE · ORAL
CEPHALEXINDiscontinued
CEPHALEXIN EQ 500MG BASE · CAPSULE · ORAL
Approval history
2002-08-27Manufacturing (CMC) · Supplement 35AP
1999-12-23Manufacturing (CMC) · Supplement 34AP
1999-06-01Manufacturing (CMC) · Supplement 33AP
1998-01-28Manufacturing (CMC) · Supplement 32AP
1996-07-12Labeling · Supplement 31AP
1993-10-01Labeling · Supplement 30AP
1992-11-24Labeling · Supplement 27AP
1992-04-13Manufacturing (CMC) · Supplement 25AP
1992-02-07Labeling · Supplement 24AP
1988-10-20Labeling · Supplement 22AP
1978-03-27OriginalAP
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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