APPLICATION
ANDA075294
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-28
LATEST ACTION
2016-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
RANITIDINE HYDROCHLORIDEOver-the-counter
RANITIDINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
Approval history
2016-02-23Labeling · Supplement 32 · standardAP
2016-02-23Labeling · Supplement 31 · standardAP
2015-04-15Manufacturing (CMC) · Supplement 30AP
2010-11-01Labeling · Supplement 24AP
2009-08-31Labeling · Supplement 22AP
2009-04-06Labeling · Supplement 20AP
2002-03-21Labeling · Supplement 12AP
2001-03-16Labeling · Supplement 6AP
2001-03-16Manufacturing (CMC) · Supplement 7AP
2001-03-16Manufacturing (CMC) · Supplement 3AP
2001-03-09Manufacturing (CMC) · Supplement 8AP
2001-03-09Manufacturing (CMC) · Supplement 10AP
2001-03-09Labeling · Supplement 9AP
2001-03-09Manufacturing (CMC) · Supplement 11AP
2000-11-15Manufacturing (CMC) · Supplement 4AP
2000-11-15Manufacturing (CMC) · Supplement 5AP
2000-08-10Manufacturing (CMC) · Supplement 2AP
2000-08-10Manufacturing (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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