RUBICON FDA Approval ANDA 078625

ANDA 078625

RUBICON

FDA Drug Application

Application #078625

Documents

Letter2012-02-14

Application Sponsors

ANDA 078625RUBICON

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL25MG0LAMOTRIGINELAMOTRIGINE
002TABLET;ORAL100MG0LAMOTRIGINELAMOTRIGINE
003TABLET;ORAL150MG0LAMOTRIGINELAMOTRIGINE
004TABLET;ORAL200MG0LAMOTRIGINELAMOTRIGINE

FDA Submissions

ORIG1AP2009-01-27
LABELING; LabelingSUPPL4AP2015-02-18STANDARD
LABELING; LabelingSUPPL5AP2015-02-18STANDARD
LABELING; LabelingSUPPL6AP2015-02-18STANDARD
LABELING; LabelingSUPPL7AP2015-12-23STANDARD
LABELING; LabelingSUPPL8AP2015-12-23STANDARD
LABELING; LabelingSUPPL9AP2015-12-23STANDARD
LABELING; LabelingSUPPL10AP2020-01-29STANDARD
LABELING; LabelingSUPPL11AP2020-01-29STANDARD
LABELING; LabelingSUPPL12AP2020-01-29STANDARD
LABELING; LabelingSUPPL14AP2021-10-29STANDARD

Submissions Property Types

SUPPL1Null7
SUPPL4Null15
SUPPL5Null15
SUPPL6Null7
SUPPL7Null7
SUPPL8Null15
SUPPL9Null15
SUPPL10Null15
SUPPL11Null7
SUPPL12Null7
SUPPL14Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

RUBICON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78625
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMOTRIGINE","activeIngredients":"LAMOTRIGINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LAMOTRIGINE","submission":"LAMOTRIGINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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