APPLICATION
ANDA075122
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-19
LATEST ACTION
2003-02-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CIMETIDINEDiscontinued
CIMETIDINE 100MG · TABLET · ORAL
CIMETIDINEDiscontinued
CIMETIDINE 200MG · TABLET · ORAL
Approval history
2003-02-03Labeling · Supplement 6AP
2003-01-10Labeling · Supplement 4AP
2002-11-20Manufacturing (CMC) · Supplement 5AP
2000-11-27Labeling · Supplement 1AP
2000-05-02Manufacturing (CMC) · Supplement 2AP
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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