Application 020095

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZANTAC 150RANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ZANTAC 300RANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21146SUPPL2004-07-01
41142SUPPL2003-04-29
20470SUPPL2003-04-29
21147SUPPL2002-01-07