ANDA 077747

RUBICON

FDA Drug Application

Application #077747

Documents

• Review: 2011-02-15
• Other Important Information from FDA: 2008-04-25
• Other: 2011-02-15

Application Sponsors

ANDA 077747

RUBICON

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	150MG	0	OXCARBAZEPINE	OXCARBAZEPINE
002	TABLET;ORAL	300MG	0	OXCARBAZEPINE	OXCARBAZEPINE
003	TABLET;ORAL	600MG	0	OXCARBAZEPINE	OXCARBAZEPINE

FDA Submissions

	ORIG	1	AP	2008-04-09
LABELING; Labeling	SUPPL	3	AP	2010-04-29
LABELING; Labeling	SUPPL	4	AP	2010-10-22
LABELING; Labeling	SUPPL	6	AP	2013-04-26
LABELING; Labeling	SUPPL	7	AP	2014-12-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-12-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-08-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2022-08-04	UNKNOWN

Submissions Property Types

SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)