ANDA 089422

PAR PHARM

FDA Drug Application

Application #089422

Application Sponsors

ANDA 089422

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

IMIPRAMINE HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-08-19
LABELING; Labeling	SUPPL	6	AP	1991-01-07
LABELING; Labeling	SUPPL	7	AP	1993-11-05
LABELING; Labeling	SUPPL	8	AP	1995-10-23
LABELING; Labeling	SUPPL	9	AP	1996-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-10-02

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89422
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIPRAMINE HYDROCHLORIDE","activeIngredients":"IMIPRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IMIPRAMINE HYDROCHLORIDE","submission":"IMIPRAMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)