APPLICATION
ANDA074246
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-17
LATEST ACTION
2014-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CIMETIDINEPrescription
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 200MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 800MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 300MG · TABLET · ORAL
Approval history
2014-01-07Labeling · Supplement 14 · standardAP
2002-10-03Manufacturing (CMC) · Supplement 7AP
1998-02-05Manufacturing (CMC) · Supplement 6AP
1996-04-29Labeling · Supplement 5AP
1996-04-17Manufacturing (CMC) · Supplement 4AP
1995-09-21Manufacturing (CMC) · Supplement 3AP
1995-02-07Labeling · Supplement 1AP
1995-02-07Manufacturing (CMC) · Supplement 2AP
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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