APPLICATION
ANDA074488
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-31
LATEST ACTION
2007-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 300MG BASE · TABLET · ORAL
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
Approval history
2007-08-30Labeling · Supplement 22AP
2003-08-01Labeling · Supplement 19AP
2003-03-19Labeling · Supplement 17AP
2001-12-13Manufacturing (CMC) · Supplement 16AP
2001-12-13Manufacturing (CMC) · Supplement 14AP
2001-12-13Manufacturing (CMC) · Supplement 15AP
2001-12-13Manufacturing (CMC) · Supplement 13AP
2001-05-22Manufacturing (CMC) · Supplement 18AP
2000-09-11Labeling · Supplement 12AP
2000-08-30Manufacturing (CMC) · Supplement 3AP
2000-08-30Manufacturing (CMC) · Supplement 6AP
2000-08-30Manufacturing (CMC) · Supplement 4AP
2000-08-30Labeling · Supplement 5AP
2000-04-06Labeling · Supplement 10AP
2000-04-06Labeling · Supplement 11AP
1999-07-14Manufacturing (CMC) · Supplement 7AP
1999-06-15Manufacturing (CMC) · Supplement 2AP
1999-06-07Manufacturing (CMC) · Supplement 8AP
1999-03-12Manufacturing (CMC) · Supplement 1AP
1997-07-31OriginalAP
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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