WATSON LABS TEVA FDA Approval ANDA 075152

ANDA 075152

WATSON LABS TEVA

FDA Drug Application

Application #075152

Documents

Letter1998-11-27

Application Sponsors

ANDA 075152WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM

FDA Submissions

ORIG1AP1998-11-27
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-08-31
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-11-07

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75152
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC POTASSIUM","activeIngredients":"DICLOFENAC POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICLOFENAC POTASSIUM","submission":"DICLOFENAC POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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