APPLICATION
ANDA074151
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-17
LATEST ACTION
2012-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CIMETIDINEPrescription
CIMETIDINE 300MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 200MG · TABLET · ORAL
Approval history
2012-11-13Labeling · Supplement 20AP
2007-03-16Labeling · Supplement 19AP
2000-02-01Manufacturing (CMC) · Supplement 15AP
1999-01-21Manufacturing (CMC) · Supplement 14AP
1998-05-18Manufacturing (CMC) · Supplement 13AP
1998-03-25Manufacturing (CMC) · Supplement 12AP
1996-06-26Manufacturing (CMC) · Supplement 6AP
1996-06-26Manufacturing (CMC) · Supplement 4AP
1996-06-26Manufacturing (CMC) · Supplement 7AP
1996-06-26Manufacturing (CMC) · Supplement 5AP
1996-01-31Manufacturing (CMC) · Supplement 2AP
1996-01-31Labeling · Supplement 3AP
1996-01-31Manufacturing (CMC) · Supplement 1AP
1995-12-22Labeling · Supplement 9AP
1994-05-17OriginalAP
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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