PIRAMAL CRITICAL FDA Approval ANDA 074416

ANDA 074416

PIRAMAL CRITICAL

FDA Drug Application

Application #074416

Application Sponsors

ANDA 074416PIRAMAL CRITICAL

Marketing Status

Prescription001

Application Products

001LIQUID;INHALATION99.9%0ISOFLURANEISOFLURANE

FDA Submissions

ORIG1AP1994-09-30
LABELING; LabelingSUPPL3AP2000-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-01-03
LABELING; LabelingSUPPL7AP2015-02-06

Submissions Property Types

SUPPL4Null0
SUPPL5Null0
SUPPL7Null7

TE Codes

001PrescriptionAN

CDER Filings

PIRAMAL CRITICAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74416
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOFLURANE","activeIngredients":"ISOFLURANE","strength":"99.9%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOFLURANE","submission":"ISOFLURANE","actionType":"99.9%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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