NDA 020239

ROCHE

FDA Drug Application

Application #020239

Documents

• Letter: 2004-08-25
• Letter: 2005-11-30
• Letter: 2009-11-12
• Letter: 2011-09-19
• Label: 2004-08-25
• Label: 2005-11-30
• Label: 2009-10-14
• Label: 2011-05-02
• Review: 2008-08-11
• Review: 2009-09-16
• Review: 2009-09-16
• Letter: 2002-08-16
• Letter: 2004-09-21
• Letter: 2004-09-21
• Label: 2002-08-16
• Review: 2009-01-12
• Review: 2009-09-16
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 020239

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	INJECTABLE;INJECTION	EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	KYTRIL	GRANISETRON HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	KYTRIL	GRANISETRON HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	KYTRIL	GRANISETRON HYDROCHLORIDE
004	INJECTABLE;INJECTION	EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	KYTRIL	GRANISETRON HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-12-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	1997-01-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	1995-11-21	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1997-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-05-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	1997-03-20	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2002-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-11-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2004-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2004-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2004-09-17	STANDARD
LABELING; Labeling	SUPPL	18	AP	2005-11-23	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-10-07	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2011-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20239
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 3MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2011","submission":"SUPPL-23","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020239s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020239s021,020305s014,021238s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2005","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020239s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2004","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20239s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2002","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21239s8lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 3MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 0.1MG BASE\/ML (EQ 0.1MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-04-29
        )

)