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FDA ANDA · ANDA074329

CIMETIDINE

Sponsor: CHARTWELL MOLECULES

APPLICATION
ANDA074329
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-17
LATEST ACTION
1999-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CIMETIDINEPrescription
CIMETIDINE 400MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 200MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 300MG · TABLET · ORAL
CIMETIDINEPrescription
CIMETIDINE 800MG · TABLET · ORAL

Approval history

1999-07-23Manufacturing (CMC) · Supplement 5AP
1999-07-23Manufacturing (CMC) · Supplement 6AP
1996-05-08Labeling · Supplement 4AP
1995-02-17Manufacturing (CMC) · Supplement 3AP
1994-12-19Manufacturing (CMC) · Supplement 1AP
1994-12-19Manufacturing (CMC) · Supplement 2AP
1994-05-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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