WATSON LABS TEVA FDA Approval ANDA 072952

ANDA 072952

WATSON LABS TEVA

FDA Drug Application

Application #072952

Application Sponsors

ANDA 072952WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL10MG0OXAZEPAMOXAZEPAM

FDA Submissions

ORIG1AP1990-09-28
LABELING; LabelingSUPPL2AP1993-10-19
LABELING; LabelingSUPPL3AP1998-04-21
LABELING; LabelingSUPPL5AP2016-12-16STANDARD
LABELING; LabelingSUPPL6AP2021-02-05STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL5Null15
SUPPL6Null7

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72952
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXAZEPAM","activeIngredients":"OXAZEPAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXAZEPAM","submission":"OXAZEPAM","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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