PIRAMAL CRITICAL FDA Approval ANDA 074396

ANDA 074396

PIRAMAL CRITICAL

FDA Drug Application

Application #074396

Application Sponsors

ANDA 074396PIRAMAL CRITICAL

Marketing Status

Discontinued001

Application Products

001LIQUID;INHALATION99.9%0ENFLURANEENFLURANE

FDA Submissions

ORIG1AP1994-07-29
LABELING; LabelingSUPPL2AP1997-12-15
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-10-14
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-11-30

Submissions Property Types

SUPPL5Null0
SUPPL6Null0

CDER Filings

PIRAMAL CRITICAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74396
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENFLURANE","activeIngredients":"ENFLURANE","strength":"99.9%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENFLURANE","submission":"ENFLURANE","actionType":"99.9%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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