FDA.reportPublic FDA data

Application 021238

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYTRILGRANISETRON HYDROCHLORIDESOLUTION;ORALEQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
27173SUPPL2009-11-12
36432SUPPL2009-10-14
36431SUPPL2005-11-30
4733SUPPL2005-11-30
36430ORIG2001-06-27
21533ORIG2001-06-27
4732ORIG2001-06-27