SUN PHARM INDUSTRIES FDA Approval ANDA 084557

ANDA 084557

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084557

Application Sponsors

ANDA 084557SUN PHARM INDUSTRIES

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1975-07-29
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1987-04-15
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1992-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1992-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1994-10-11
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1994-12-23
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1998-12-01

Submissions Property Types

SUPPL20Null0
SUPPL21Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0

CDER Filings

SUN PHARM INDUSTRIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84557
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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