FDA.reportPublic FDA data

Application 019675

Type
NDA
Sponsor
GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZANTACRANITIDINE HYDROCHLORIDESYRUP;ORALEQ 15MG BASE/MLYesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19081SUPPL2009-11-12
11622SUPPL2009-10-06
11621SUPPL2009-03-27
1488SUPPL2009-02-19
17546SUPPL2006-07-21
11620SUPPL2005-05-02
1487SUPPL2005-05-02
17545SUPPL2004-05-07
20287SUPPL2003-04-30
1486SUPPL2003-04-30
17544SUPPL2002-01-07
40970ORIG1998-02-04