ANDA 090239

JUBILANT CADISTA

FDA Drug Application

Application #090239

Application Sponsors

ANDA 090239

JUBILANT CADISTA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2010-01-25
LABELING; Labeling	SUPPL	4	AP	2015-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90239
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)