ANI PHARMS INC FDA Approval ANDA 089447

ANDA 089447

ANI PHARMS INC

FDA Drug Application

Application #089447

Application Sponsors

ANDA 089447ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL250MG0CHLORPROPAMIDECHLORPROPAMIDE

FDA Submissions

ORIG1AP1986-11-17
LABELING; LabelingSUPPL5AP1988-03-28
LABELING; LabelingSUPPL6AP1989-05-17
LABELING; LabelingSUPPL8AP1991-07-30

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89447
            [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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.