SUN PHARM INDUSTRIES FDA Approval ANDA 089970

ANDA 089970

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089970

Application Sponsors

ANDA 089970SUN PHARM INDUSTRIES

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG0CHLORZOXAZONECHLORZOXAZONE

FDA Submissions

ORIG1AP1990-09-27
LABELING; LabelingSUPPL2AP1993-06-30
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1994-01-12
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1994-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1995-06-22
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1997-02-24
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1997-12-05
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-05-16
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-05-16

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0

CDER Filings

SUN PHARM INDUSTRIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89970
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORZOXAZONE","submission":"CHLORZOXAZONE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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