ROCHE FDA Approval NDA 021238

NDA 021238

ROCHE

FDA Drug Application

Application #021238

Documents

Letter2001-06-27
Letter2005-11-30
Review2001-06-27
Letter2009-11-12
Label2001-06-27
Label2005-11-30
Label2009-10-14

Application Sponsors

NDA 021238ROCHE

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORALEQ 2MG BASE/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1KYTRILGRANISETRON HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2001-06-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-11-25STANDARD
LABELING; LabelingSUPPL5AP2005-11-23STANDARD
LABELING; LabelingSUPPL7AP2009-10-07STANDARD

Submissions Property Types

ORIG1Null0
SUPPL3Null0
SUPPL5Null0
SUPPL7Null0

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HYDROCHLORIDE","strength":"EQ 2MG BASE\/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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HYDROCHLORIDE","actionType":"EQ 2MG BASE\/10ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":"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
        )

)

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