APPLICATION
ANDA074424
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-28
LATEST ACTION
2007-03-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CIMETIDINEDiscontinued
CIMETIDINE 800MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 300MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 200MG · TABLET · ORAL
Approval history
2007-03-22Labeling · Supplement 20AP
2002-07-29Manufacturing (CMC) · Supplement 15AP
2002-03-12Manufacturing (CMC) · Supplement 14AP
2000-01-28Manufacturing (CMC) · Supplement 12AP
1999-07-08Manufacturing (CMC) · Supplement 11AP
1999-03-12Manufacturing (CMC) · Supplement 10AP
1998-05-26Labeling · Supplement 9AP
1996-12-17Manufacturing (CMC) · Supplement 3AP
1996-12-17Manufacturing (CMC) · Supplement 8AP
1996-12-17Manufacturing (CMC) · Supplement 6AP
1996-12-17Manufacturing (CMC) · Supplement 4AP
1996-12-17Manufacturing (CMC) · Supplement 2AP
1996-12-17Labeling · Supplement 7AP
1996-02-13Manufacturing (CMC) · Supplement 1AP
1995-07-28OriginalAP
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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