APPLICATION
ANDA074401
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-30
LATEST ACTION
1999-08-18
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
1999-08-18Manufacturing (CMC) · Supplement 6AP
1997-05-30Manufacturing (CMC) · Supplement 5AP
1996-10-30Manufacturing (CMC) · Supplement 3AP
1996-10-30Manufacturing (CMC) · Supplement 1AP
1996-10-30Labeling · Supplement 4AP
1996-10-30Manufacturing (CMC) · Supplement 2AP
1995-05-30OriginalAP
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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