ANDA 078005

ANI PHARMS INC

FDA Drug Application

Application #078005

Documents

• Review: 2011-02-15
• Healthcare Professional Sheet: 2007-12-21

Application Sponsors

ANDA 078005

ANI PHARMS INC

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	2007-12-11
LABELING; Labeling	SUPPL	2	AP	2010-06-29
LABELING; Labeling	SUPPL	3	AP	2010-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2012-01-20
LABELING; Labeling	SUPPL	6	AP	2020-10-27	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-10-27	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78005
            [companyName] => ANI PHARMS INC
            [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
        )

)