ANDA 089488

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089488

Application Sponsors

ANDA 089488

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

25MG

0

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-01-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89488
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)