RUBICON FDA Approval ANDA 077747

ANDA 077747

RUBICON

FDA Drug Application

Application #077747

Documents

Review2011-02-15
Other Important Information from FDA2008-04-25
Other2011-02-15

Application Sponsors

ANDA 077747RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL150MG0OXCARBAZEPINEOXCARBAZEPINE
002TABLET;ORAL300MG0OXCARBAZEPINEOXCARBAZEPINE
003TABLET;ORAL600MG0OXCARBAZEPINEOXCARBAZEPINE

FDA Submissions

ORIG1AP2008-04-09
LABELING; LabelingSUPPL3AP2010-04-29
LABELING; LabelingSUPPL4AP2010-10-22
LABELING; LabelingSUPPL6AP2013-04-26
LABELING; LabelingSUPPL7AP2014-12-19STANDARD
LABELING; LabelingSUPPL9AP2014-12-19STANDARD
LABELING; LabelingSUPPL10AP2020-08-26STANDARD
LABELING; LabelingSUPPL11AP2020-08-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2022-08-04UNKNOWN

Submissions Property Types

SUPPL6Null15
SUPPL7Null7
SUPPL9Null7
SUPPL10Null7
SUPPL11Null15
SUPPL12Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77747
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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