WATSON LABS INC FDA Approval ANDA 074393

ANDA 074393

WATSON LABS INC

FDA Drug Application

Application #074393

Application Sponsors

ANDA 074393WATSON LABS INC

Marketing Status

Discontinued001

Application Products

001LIQUID;INHALATION99.9%0ISOFLURANEISOFLURANE

FDA Submissions

ORIG1AP1995-05-12
LABELING; LabelingSUPPL2AP1996-03-25
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-09-19
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-04-23
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-04-23
LABELING; LabelingSUPPL8AP1999-04-23
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1999-04-23
LABELING; LabelingSUPPL10AP1999-07-27
LABELING; LabelingSUPPL11AP1999-11-10
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-12-08

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL12Null0

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74393
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOFLURANE","activeIngredients":"ISOFLURANE","strength":"99.9%","dosageForm":"LIQUID;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOFLURANE","submission":"ISOFLURANE","actionType":"99.9%","submissionClassification":"LIQUID;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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