FDA ANDA · ANDA074463

CIMETIDINE

Sponsor: TEVA

APPLICATION

ANDA074463

TYPE

ANDA

ORIGINAL APPROVAL

1994-05-17

LATEST ACTION

2012-11-13

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

CIMETIDINEPrescription

CIMETIDINE 800MG · TABLET · ORAL

2012-11-13Labeling · Supplement 16AP

2007-03-16Labeling · Supplement 15AP

2000-02-01Manufacturing (CMC) · Supplement 12AP

1999-02-22Manufacturing (CMC) · Supplement 11AP

1998-05-18Manufacturing (CMC) · Supplement 10AP

1996-07-02Manufacturing (CMC) · Supplement 4AP

1996-07-02Manufacturing (CMC) · Supplement 7AP

1996-07-02Manufacturing (CMC) · Supplement 5AP

1996-06-02Manufacturing (CMC) · Supplement 6AP

1996-01-31Manufacturing (CMC) · Supplement 1AP

1996-01-31Manufacturing (CMC) · Supplement 2AP

1996-01-31Labeling · Supplement 3AP

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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