NDA 021822

BOEHRINGER INGELHEIM

FDA Drug Application

Application #021822

Documents

• Letter: 2008-06-26
• Label: 2008-06-26
• Review: 2010-04-21
• Summary Review: 2010-04-21

Application Sponsors

NDA 021822

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; ORAL

100MG/ML

2

APTIVUS

TIPRANAVIR

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2008-06-23

PRIORITY

Submissions Property Types

ORIG

1

Null

41

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21822
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"APTIVUS","activeIngredients":"TIPRANAVIR","strength":"100MG\/ML","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/23\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021822LBL.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"APTIVUS","submission":"TIPRANAVIR","actionType":"100MG\/ML","submissionClassification":"SOLUTION; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"}]
            [supplements] => 
            [actionDate] => 2008-06-23
        )

)