NDA 021238

ROCHE

FDA Drug Application

Application #021238

Documents

• Letter: 2001-06-27
• Letter: 2005-11-30
• Review: 2001-06-27
• Letter: 2009-11-12
• Label: 2001-06-27
• Label: 2005-11-30
• Label: 2009-10-14

Application Sponsors

NDA 021238

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

EQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

KYTRIL

GRANISETRON HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-06-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-11-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-11-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2009-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21238
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KYTRIL","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2009","submission":"SUPPL-7","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-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020305s010,021238s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21238lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KYTRIL","submission":"GRANISETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE\/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-10-07
        )

)