APPLICATION
ANDA062205
TYPE
ANDA
ORIGINAL APPROVAL
1979-07-28
LATEST ACTION
2000-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CEFACLORDiscontinued
CEFACLOR EQ 250MG BASE · CAPSULE · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 500MG BASE · CAPSULE · ORAL
Approval history
2000-05-01Manufacturing (CMC) · Supplement 51AP
2000-02-15Manufacturing (CMC) · Supplement 50AP
2000-02-15Manufacturing (CMC) · Supplement 49AP
1999-12-23Manufacturing (CMC) · Supplement 48AP
1999-08-30Labeling · Supplement 47AP
1999-03-03Manufacturing (CMC) · Supplement 46AP
1998-09-30Labeling · Supplement 45AP
1998-01-30Manufacturing (CMC) · Supplement 43AP
1997-10-23Labeling · Supplement 42AP
1997-04-07Manufacturing (CMC) · Supplement 36AP
1997-04-01Labeling · Supplement 41AP
1996-06-10Labeling · Supplement 37AP
1994-07-13Labeling · Supplement 29AP
1994-06-02Labeling · Supplement 35AP
1994-05-24Labeling · Supplement 32AP
1992-12-03Manufacturing (CMC) · Supplement 28AP
1992-06-23Manufacturing (CMC) · Supplement 31AP
1992-06-23Manufacturing (CMC) · Supplement 30AP
1991-08-19Manufacturing (CMC) · Supplement 25AP
1989-01-26Manufacturing (CMC) · Supplement 16AP
1979-07-28OriginalAP
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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