ABBOTT FDA Approval NDA 020680

NDA 020680

ABBOTT

FDA Drug Application

Application #020680

Documents

Review2007-11-19
Review2005-04-27

Application Sponsors

NDA 020680ABBOTT

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL100MG0NORVIRRITONAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1996-03-01PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-10-01PRIORITY
LABELING; LabelingSUPPL4AP1996-09-24PRIORITY
LABELING; LabelingSUPPL5AP1997-01-08PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1997-07-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1997-09-12PRIORITY
LABELING; LabelingSUPPL8AP1997-10-31PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-05-21PRIORITY
LABELING; LabelingSUPPL10AP1998-02-12PRIORITY
EFFICACY; EfficacySUPPL11AP1999-05-26PRIORITY
LABELING; LabelingSUPPL12AP1999-04-29PRIORITY
LABELING; LabelingSUPPL13AP1999-04-12PRIORITY
LABELING; LabelingSUPPL14AP1999-04-09PRIORITY

Submissions Property Types

ORIG1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20680
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORVIR","activeIngredients":"RITONAVIR","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORVIR","submission":"RITONAVIR","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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