PIRAMAL CRITICAL FDA Approval ANDA 077867

ANDA 077867

PIRAMAL CRITICAL

FDA Drug Application

Application #077867

Application Sponsors

ANDA 077867PIRAMAL CRITICAL

Marketing Status

Prescription001

Application Products

001LIQUID;INHALATION100%0SOJOURNSEVOFLURANE

FDA Submissions

ORIG1AP2007-05-02
LABELING; LabelingSUPPL4AP2011-03-16
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2012-01-20
LABELING; LabelingSUPPL8AP2012-01-31
LABELING; LabelingSUPPL9AP2015-09-16STANDARD
LABELING; LabelingSUPPL11AP2015-09-16STANDARD
LABELING; LabelingSUPPL12AP2015-09-16STANDARD
LABELING; LabelingSUPPL18AP2020-03-25STANDARD

Submissions Property Types

SUPPL7Null15
SUPPL8Null15
SUPPL9Null15
SUPPL11Null15
SUPPL12Null15
SUPPL18Null7

TE Codes

001PrescriptionAN

CDER Filings

PIRAMAL CRITICAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77867
            [companyName] => PIRAMAL CRITICAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOJOURN","activeIngredients":"SEVOFLURANE","strength":"100%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SOJOURN","submission":"SEVOFLURANE","actionType":"100%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.