ANDA 071479

PLIVA

FDA Drug Application

Application #071479

Documents

• Healthcare Professional Sheet: 2008-02-01

Application Sponsors

ANDA 071479

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

CARBAMAZEPINE

CARBAMAZEPINE

FDA Submissions

	ORIG	1	AP	1987-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-04-29
LABELING; Labeling	SUPPL	5	AP	1991-02-11
LABELING; Labeling	SUPPL	6	AP	1992-06-04
LABELING; Labeling	SUPPL	7	AP	1993-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-04-17
LABELING; Labeling	SUPPL	10	AP	1998-12-16
LABELING; Labeling	SUPPL	11	AP	2002-04-30

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71479
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBAMAZEPINE","submission":"CARBAMAZEPINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)