WATSON LABS TEVA FDA Approval ANDA 073353

ANDA 073353

WATSON LABS TEVA

FDA Drug Application

Application #073353

Application Sponsors

ANDA 073353WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL100MG0ATENOLOLATENOLOL

FDA Submissions

ORIG1AP1991-12-27
LABELING; LabelingSUPPL2AP1992-07-06
LABELING; LabelingSUPPL3AP1992-12-07
LABELING; LabelingSUPPL6AP1993-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1993-07-22
LABELING; LabelingSUPPL9AP1994-03-31
LABELING; LabelingSUPPL10AP1994-11-08
LABELING; LabelingSUPPL11AP1996-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1997-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-12-15
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-12-15
LABELING; LabelingSUPPL17AP2000-08-07
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2001-04-25
LABELING; LabelingSUPPL19AP2001-03-30
LABELING; LabelingSUPPL22AP2003-09-25
LABELING; LabelingSUPPL25AP2006-06-22
LABELING; LabelingSUPPL26AP2006-12-13

Submissions Property Types

SUPPL1Null0
SUPPL6Null1
SUPPL7Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL18Null0

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73353
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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