ANDA 084555

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084555

Application Sponsors

ANDA 084555

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

12.5MG

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1987-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-12-01

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84555
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)