WATSON LABS TEVA FDA Approval ANDA 088852

ANDA 088852

WATSON LABS TEVA

FDA Drug Application

Application #088852

Application Sponsors

ANDA 088852WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL100MG0CHLORPROPAMIDECHLORPROPAMIDE

FDA Submissions

ORIG1AP1984-09-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1987-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1988-04-25
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1988-04-25
LABELING; LabelingSUPPL8AP1988-06-22
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1990-06-29
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1991-05-31
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1991-01-28
LABELING; LabelingSUPPL13AP1991-11-27
LABELING; LabelingSUPPL14AP1991-12-26

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88852
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROPAMIDE","activeIngredients":"CHLORPROPAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROPAMIDE","submission":"CHLORPROPAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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