APPLICATION
ANDA064155
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-02
LATEST ACTION
2001-03-23
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEFACLORDiscontinued
CEFACLOR EQ 375MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2001-03-23Manufacturing (CMC) · Supplement 5AP
2000-02-23Labeling · Supplement 4AP
1999-08-30Labeling · Supplement 2AP
1999-04-28Manufacturing (CMC) · Supplement 1AP
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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