NDA 020305

ROCHE

FDA Drug Application

Application #020305

Documents

• Letter: 2005-11-30
• Letter: 2009-11-12
• Label: 2009-10-14
• Review: 2009-09-16
• Letter: 1999-07-27
• Label: 2005-11-30
• Review: 1997-10-06
• Review: 1999-07-27

Application Sponsors

NDA 020305

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**	1	KYTRIL	GRANISETRON HYDROCHLORIDE
002	TABLET;ORAL	EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**	1	KYTRIL	GRANISETRON HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-06-15	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1999-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-11-25	STANDARD
LABELING; Labeling	SUPPL	10	AP	2005-11-23	STANDARD
LABELING; Labeling	SUPPL	14	AP	2009-10-07	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	8	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20305
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2009","submission":"SUPPL-14","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-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020305s010,021238s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-10-07
        )

)