ANI PHARMS INC FDA Approval ANDA 088813

ANDA 088813

ANI PHARMS INC

FDA Drug Application

Application #088813

Application Sponsors

ANDA 088813ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL250MG0CHLORPROPAMIDECHLORPROPAMIDE

FDA Submissions

ORIG1AP1984-10-19
LABELING; LabelingSUPPL14AP1988-05-09
LABELING; LabelingSUPPL15AP1989-05-19
LABELING; LabelingSUPPL16AP1991-07-16

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88813
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROPAMIDE","activeIngredients":"CHLORPROPAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROPAMIDE","submission":"CHLORPROPAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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