AMNEAL PHARMS FDA Approval ANDA 215576

ANDA 215576

AMNEAL PHARMS

FDA Drug Application

Application #215576

Application Sponsors

ANDA 215576AMNEAL PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL1GM0SUCRALFATESUCRALFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215576
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCRALFATE","activeIngredients":"SUCRALFATE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUCRALFATE","submission":"SUCRALFATE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.