NDA 022072

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #022072

Documents

• Letter: 2006-07-03
• Label: 2006-07-03
• Letter: 2008-06-03
• Letter: 2010-08-09
• Review: 2006-09-06

Application Sponsors

NDA 022072

BRISTOL MYERS SQUIBB

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

70MG

0

SPRYCEL

DASATINIB

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)	ORIG	1	AP	2006-06-28	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2010-07-28	STANDARD

Submissions Property Types

ORIG	1	Null	10
SUPPL	2	Null	7

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22072
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"70MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/28\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/022072lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"70MG","submissionClassification":"TABLET; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-06-28
        )

)