Application 020239

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYTRILGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002KYTRILGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003KYTRILGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004KYTRILGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
2229SUPPL2011-09-19
12356SUPPL2011-05-02
2228SUPPL2009-11-12
12355SUPPL2009-10-14
41224SUPPL2009-09-16
20551SUPPL2009-09-16
20550SUPPL2009-09-16
41223SUPPL2009-01-12
20549SUPPL2008-08-11
12354SUPPL2005-11-30
2227SUPPL2005-11-30
24636SUPPL2004-09-21
24635SUPPL2004-09-21
12353SUPPL2004-08-25
2226SUPPL2004-08-25
34411SUPPL2002-08-16
24634SUPPL2002-08-16
54111ORIG1900-01-01
54110ORIG1900-01-01
54109ORIG1900-01-01