CIPLA LTD FDA Approval ANDA 077383

ANDA 077383

CIPLA LTD

FDA Drug Application

Application #077383

Application Sponsors

ANDA 077383CIPLA LTD

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION50MG/VIAL0CARBOPLATINCARBOPLATIN
002INJECTABLE;INJECTION150MG/VIAL0CARBOPLATINCARBOPLATIN
003INJECTABLE;INJECTION450MG/VIAL0CARBOPLATINCARBOPLATIN

FDA Submissions

ORIG1AP2006-01-27

CDER Filings

CIPLA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77383
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"150MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"450MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"150MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"450MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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