APPLICATION
ANDA075439
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-19
LATEST ACTION
2002-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 300MG BASE · TABLET · ORAL
Approval history
2002-10-03Manufacturing (CMC) · Supplement 7AP
2002-10-01Manufacturing (CMC) · Supplement 6AP
2001-04-04Manufacturing (CMC) · Supplement 5AP
2000-11-09Manufacturing (CMC) · Supplement 3AP
2000-11-09Manufacturing (CMC) · Supplement 4AP
2000-11-09Manufacturing (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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