APPLICATION
ANDA075497
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-14
LATEST ACTION
2003-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RANITIDINE HYDROCHLORIDEDiscontinued
RANITIDINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
Approval history
2003-04-18Labeling · Supplement 3AP
2001-10-16Manufacturing (CMC) · Supplement 2AP
2000-10-26Manufacturing (CMC) · Supplement 1AP
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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