APPLICATION
ANDA074467
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-29
LATEST ACTION
2013-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RANITIDINE HYDROCHLORIDEPrescription
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
RANITIDINE HYDROCHLORIDEPrescription
RANITIDINE HYDROCHLORIDE EQ 300MG BASE · TABLET · ORAL
Approval history
2013-02-07Labeling · Supplement 36AP
2009-05-27Labeling · Supplement 35AP
2007-12-26Labeling · Supplement 30AP
2005-04-28Labeling · Supplement 28AP
2002-11-05Manufacturing (CMC) · Supplement 25AP
2002-04-19Manufacturing (CMC) · Supplement 23AP
2001-02-27Manufacturing (CMC) · Supplement 22AP
2000-12-07Manufacturing (CMC) · Supplement 17AP
2000-12-07Manufacturing (CMC) · Supplement 18AP
2000-11-30Manufacturing (CMC) · Supplement 19AP
2000-11-30Manufacturing (CMC) · Supplement 21AP
2000-11-30Labeling · Supplement 20AP
2000-11-09Manufacturing (CMC) · Supplement 14AP
2000-05-25Labeling · Supplement 16AP
2000-03-08Labeling · Supplement 15AP
1999-08-18Manufacturing (CMC) · Supplement 8AP
1999-08-18Manufacturing (CMC) · Supplement 6AP
1999-08-18Manufacturing (CMC) · Supplement 9AP
1999-08-18Manufacturing (CMC) · Supplement 7AP
1999-06-18Manufacturing (CMC) · Supplement 11AP
1999-04-23Labeling · Supplement 5AP
1999-04-23Manufacturing (CMC) · Supplement 4AP
1998-12-08Manufacturing (CMC) · Supplement 3AP
1998-02-17Manufacturing (CMC) · Supplement 1AP
1998-02-17Manufacturing (CMC) · Supplement 2AP
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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