NDA 022310

ASTRAZENECA

FDA Drug Application

Application #022310

Documents

• Label: 2009-01-06
• Letter: 2008-12-29
• Review: 2009-09-30
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 022310

ASTRAZENECA

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

50MG

2

CASODEX

BICALUTAMIDE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2008-12-19

PRIORITY

Submissions Property Types

ORIG

1

Null

8

TE Codes

001

Prescription

TBD

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22310
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CASODEX","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/19\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022310lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CASODEX","submission":"BICALUTAMIDE","actionType":"50MG","submissionClassification":"TABLET; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"}]
            [supplements] => 
            [actionDate] => 2008-12-19
        )

)