WATSON LABS TEVA FDA Approval ANDA 070548

ANDA 070548

WATSON LABS TEVA

FDA Drug Application

Application #070548

Application Sponsors

ANDA 070548WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL10MG0PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE

FDA Submissions

ORIG1AP1986-07-10
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1987-02-05
LABELING; LabelingSUPPL3AP1987-08-10
LABELING; LabelingSUPPL4AP1988-12-22
LABELING; LabelingSUPPL5AP1990-02-28
LABELING; LabelingSUPPL6AP1990-07-26
LABELING; LabelingSUPPL7AP1990-09-10
LABELING; LabelingSUPPL11AP1991-02-04
LABELING; LabelingSUPPL12AP1992-06-04
LABELING; LabelingSUPPL13AP1999-02-09
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1999-11-10
LABELING; LabelingSUPPL15AP1999-11-17
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-08-31

Submissions Property Types

SUPPL2Null0
SUPPL14Null0
SUPPL16Null0

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70548
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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