ANDA 084554

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084554

Application Sponsors

ANDA 084554

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1975-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-12-01

Submissions Property Types

SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84554
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)