SUN PHARMA GLOBAL FDA Approval ANDA 077703

ANDA 077703

SUN PHARMA GLOBAL

FDA Drug Application

Application #077703

Application Sponsors

ANDA 077703SUN PHARMA GLOBAL

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION30MG/VIAL0PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM
002INJECTABLE;INJECTION90MG/VIAL0PAMIDRONATE DISODIUMPAMIDRONATE DISODIUM

FDA Submissions

ORIG1AP2008-12-24

CDER Filings

SUN PHARMA GLOBAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77703
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"30MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PAMIDRONATE DISODIUM","activeIngredients":"PAMIDRONATE DISODIUM","strength":"90MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"30MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PAMIDRONATE DISODIUM","submission":"PAMIDRONATE DISODIUM","actionType":"90MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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