APPLICATION
ANDA074100
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-31
LATEST ACTION
2002-04-19
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
2002-04-19Manufacturing (CMC) · Supplement 18AP
2001-12-13Labeling · Supplement 14AP
2001-12-13Manufacturing (CMC) · Supplement 12AP
2001-12-13Manufacturing (CMC) · Supplement 15AP
2001-12-13Manufacturing (CMC) · Supplement 13AP
2001-07-05Manufacturing (CMC) · Supplement 10AP
2001-05-09Manufacturing (CMC) · Supplement 17AP
2001-04-04Manufacturing (CMC) · Supplement 11AP
2000-11-28Manufacturing (CMC) · Supplement 9AP
2000-06-29Manufacturing (CMC) · Supplement 8AP
1999-05-04Labeling · Supplement 5AP
1999-05-04Manufacturing (CMC) · Supplement 4AP
1999-01-14Manufacturing (CMC) · Supplement 6AP
1997-09-24Manufacturing (CMC) · Supplement 3AP
1996-08-19Manufacturing (CMC) · Supplement 1AP
1996-08-19Manufacturing (CMC) · Supplement 2AP
1995-01-31OriginalAP
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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