WATSON LABS INC FDA Approval ANDA 074944

ANDA 074944

WATSON LABS INC

FDA Drug Application

Application #074944

Documents

Review2003-08-04
Letter1998-07-28

Application Sponsors

ANDA 074944WATSON LABS INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10MG/ML0ATRACURIUM BESYLATE PRESERVATIVE FREEATRACURIUM BESYLATE

FDA Submissions

ORIG1AP1998-07-28
LABELING; LabelingSUPPL2AP2016-01-26

Submissions Property Types

SUPPL1Null0
SUPPL2Null15

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74944
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"ATRACURIUM BESYLATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATRACURIUM BESYLATE PRESERVATIVE FREE","submission":"ATRACURIUM BESYLATE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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