APPLICATION
ANDA074250
TYPE
ANDA
ORIGINAL APPROVAL
1995-06-29
LATEST ACTION
2002-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CIMETIDINEDiscontinued
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 200MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 800MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 300MG · TABLET · ORAL
Approval history
2002-11-13Manufacturing (CMC) · Supplement 16AP
2000-11-17Labeling · Supplement 15AP
2000-11-17Manufacturing (CMC) · Supplement 14AP
2000-05-01Manufacturing (CMC) · Supplement 13AP
1998-11-05Manufacturing (CMC) · Supplement 10AP
1998-11-05Manufacturing (CMC) · Supplement 9AP
1998-11-05Manufacturing (CMC) · Supplement 11AP
1998-11-05Labeling · Supplement 8AP
1998-03-25Labeling · Supplement 12AP
1997-02-10Manufacturing (CMC) · Supplement 6AP
1996-12-09Manufacturing (CMC) · Supplement 4AP
1996-12-09Manufacturing (CMC) · Supplement 7AP
1996-12-09Labeling · Supplement 5AP
1996-11-04Manufacturing (CMC) · Supplement 3AP
1995-12-15Manufacturing (CMC) · Supplement 2AP
1995-12-15Manufacturing (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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