SUN PHARM INDUSTRIES FDA Approval ANDA 086166

ANDA 086166

SUN PHARM INDUSTRIES

FDA Drug Application

Application #086166

Application Sponsors

ANDA 086166SUN PHARM INDUSTRIES

Marketing Status

Discontinued002

Application Products

002TABLET;ORAL5MG0ISOSORBIDE DINITRATEISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL12AP1982-03-02
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1983-11-21
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1984-07-13
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1986-09-19
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1986-09-19
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1986-09-19
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1987-03-31
LABELING; LabelingSUPPL29AP1990-03-07
LABELING; LabelingSUPPL30AP1990-07-25
LABELING; LabelingSUPPL31AP1991-12-19
MANUF (CMC); Manufacturing (CMC)SUPPL32AP1992-04-03
LABELING; LabelingSUPPL33AP1992-03-16
MANUF (CMC); Manufacturing (CMC)SUPPL35AP1992-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL38AP1998-12-01

Submissions Property Types

SUPPL12Null0
SUPPL17Null0
SUPPL19Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL27Null0
SUPPL32Null0
SUPPL35Null0
SUPPL38Null0

CDER Filings

SUN PHARM INDUSTRIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86166
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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