ANDA 071940

JUBILANT CADISTA

FDA Drug Application

Application #071940

Documents

• Healthcare Professional Sheet: 2008-02-01

Application Sponsors

ANDA 071940

JUBILANT CADISTA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, CHEWABLE;ORAL

100MG

0

CARBAMAZEPINE

CARBAMAZEPINE

FDA Submissions

	ORIG	1	AP	1988-02-01
LABELING; Labeling	SUPPL	4	AP	1990-01-03
LABELING; Labeling	SUPPL	6	AP	1991-03-29
LABELING; Labeling	SUPPL	7	AP	1993-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-06-23
LABELING; Labeling	SUPPL	13	AP	1997-06-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71940
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBAMAZEPINE","activeIngredients":"CARBAMAZEPINE","strength":"100MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBAMAZEPINE","submission":"CARBAMAZEPINE","actionType":"100MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)