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FDA NDA · NDA020251

ZANTAC 25

Sponsor: GLAXO GRP LTD

APPLICATION
NDA020251
TYPE
NDA
ORIGINAL APPROVAL
1994-03-31
LATEST ACTION
2009-09-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EFFERVESCENT, GRANULE, EFFERVESCENT
MARKETING STATUS
Discontinued

Products

ZANTAC 25Discontinued
RANITIDINE HYDROCHLORIDE EQ 25MG BASE · TABLET, EFFERVESCENT · ORAL
ZANTAC 150Discontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE · TABLET, EFFERVESCENT · ORAL
ZANTAC 150Discontinued
RANITIDINE HYDROCHLORIDE EQ 150MG BASE/PACKET · GRANULE, EFFERVESCENT · ORAL

Approval history

2009-09-04Labeling · Supplement 19 · standard — Label ↗AP
2009-02-20Labeling · Supplement 18 · standard — Letter ↗AP
2006-07-12Labeling · Supplement 17 · standard — Letter ↗AP
2005-04-28Labeling · Supplement 16 · standard — Letter ↗AP
2004-04-01Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2002-01-15Manufacturing (CMC) · Supplement 12 · standardAP
2002-01-07Labeling · Supplement 11 · standard — Letter ↗AP
2001-05-09Labeling · Supplement 10 · standardAP
1999-10-29Labeling · Supplement 6 · standard — Review ↗AP
1999-10-29Labeling · Supplement 9 · standardAP
1999-10-22Labeling · Supplement 7 · standardAP
1999-10-22Labeling · Supplement 8 · standardAP
1996-11-27Labeling · Supplement 5 · standardAP
1995-03-29Labeling · Supplement 4 · standardAP
1994-11-14Labeling · Supplement 3 · standardAP
1994-11-03Labeling · Supplement 1 · standardAP
1994-03-31Type 3 - New Dosage Form · Original · standardAP
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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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