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FDA NDA · NDA019675

ZANTAC

Sponsor: GLAXO GRP LTD

APPLICATION
NDA019675
TYPE
NDA
ORIGINAL APPROVAL
1988-12-30
LATEST ACTION
2009-09-04
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

ZANTAC · ReferenceDiscontinued
RANITIDINE HYDROCHLORIDE EQ 15MG BASE/ML · SYRUP · ORAL

Approval history

2009-09-04Labeling · Supplement 35 · standard — Label ↗AP
2009-02-20Labeling · Supplement 34 · standard — Label ↗AP
2006-07-12Labeling · Supplement 32 · standard — Letter ↗AP
2005-04-28Labeling · Supplement 31 · standard — Label ↗AP
2004-04-30Manufacturing (CMC) · Supplement 30 · standard — Letter ↗AP
2002-09-24Manufacturing (CMC) · Supplement 27 · standardAP
2002-01-15Manufacturing (CMC) · Supplement 26 · standardAP
2002-01-07Labeling · Supplement 25 · standard — Letter ↗AP
2001-05-09Labeling · Supplement 24 · standardAP
1999-10-29Labeling · Supplement 20 · standard — Letter ↗AP
1999-10-29Labeling · Supplement 23 · standardAP
1999-10-22Labeling · Supplement 22 · standardAP
1999-10-22Labeling · Supplement 21 · standardAP
1996-11-27Labeling · Supplement 19 · standardAP
1995-03-29Efficacy · Supplement 16 · standardAP
1995-01-30Manufacturing (CMC) · Supplement 15 · standardAP
1994-11-03Labeling · Supplement 17 · standardAP
1994-11-03Labeling · Supplement 13AP
1994-02-28Labeling · Supplement 12AP
1993-04-05Labeling · Supplement 14AP
1992-07-22Manufacturing (CMC) · Supplement 11 · standardAP
1992-05-19Labeling · Supplement 9AP
1991-11-25Labeling · Supplement 3AP
1990-12-20Manufacturing (CMC) · Supplement 8 · standardAP
1990-12-12Manufacturing (CMC) · Supplement 6 · standardAP
1990-11-21Labeling · Supplement 7AP
1990-07-16Labeling · Supplement 4AP
1989-08-08Manufacturing (CMC) · Supplement 1 · standardAP
1989-05-18Labeling · Supplement 2AP
1988-12-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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