APPLICATION
ANDA064145
TYPE
ANDA
ORIGINAL APPROVAL
1996-06-24
LATEST ACTION
2000-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
CEFACLORDiscontinued
CEFACLOR EQ 500MG BASE · CAPSULE · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 250MG BASE · CAPSULE · ORAL
Approval history
2000-01-24Manufacturing (CMC) · Supplement 4AP
1999-04-30Labeling · Supplement 3AP
1998-11-04Labeling · Supplement 2AP
1997-10-23Labeling · Supplement 1AP
1996-06-24OriginalAP
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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