SUN PHARM INDUSTRIES FDA Approval ANDA 089489

ANDA 089489

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089489

Application Sponsors

ANDA 089489SUN PHARM INDUSTRIES

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL50MG0DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1987-01-02
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1994-01-12
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-02-24
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-12-05
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-04-02
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-05-16
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-05-16

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0

CDER Filings

SUN PHARM INDUSTRIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89489
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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