APPLICATION
ANDA074568
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-27
LATEST ACTION
2005-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CIMETIDINEDiscontinued
CIMETIDINE 300MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 200MG · TABLET · ORAL
Approval history
2005-03-03Labeling · Supplement 9AP
2000-07-07Manufacturing (CMC) · Supplement 3AP
2000-05-10Manufacturing (CMC) · Supplement 2AP
1998-02-17Manufacturing (CMC) · Supplement 1AP
1997-02-27OriginalAP
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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