NDA 022214

ASTRAZENECA

FDA Drug Application

Application #022214

Documents

• Review: 2010-03-04
• Letter: 2008-12-11
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01

Application Sponsors

NDA 022214

ASTRAZENECA

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

1MG

2

ARIMIDEX

ANASTROZOLE

FDA Submissions

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

ORIG

1

AP

2008-12-05

PRIORITY

Submissions Property Types

ORIG

1

Null

8

TE Codes

001

Prescription

TBD

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22214
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARIMIDEX","activeIngredients":"ANASTROZOLE","strength":"1MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARIMIDEX","submission":"ANASTROZOLE","actionType":"1MG","submissionClassification":"TABLET; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)