APPLICATION
ANDA075132
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-14
LATEST ACTION
2008-02-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
Approval history
2008-02-29Labeling · Supplement 20AP
2003-05-23Labeling · Supplement 11AP
2002-10-03Manufacturing (CMC) · Supplement 12AP
2002-05-20Manufacturing (CMC) · Supplement 10AP
2001-04-04Manufacturing (CMC) · Supplement 9AP
2000-11-28Manufacturing (CMC) · Supplement 7AP
2000-11-28Manufacturing (CMC) · Supplement 8AP
2000-11-28Manufacturing (CMC) · Supplement 6AP
2000-06-29Labeling · Supplement 5AP
2000-06-29Manufacturing (CMC) · Supplement 3AP
2000-06-29Manufacturing (CMC) · Supplement 1AP
2000-06-29Manufacturing (CMC) · Supplement 4AP
2000-06-29Manufacturing (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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