SAGENT PHARMS INC FDA Approval ANDA 215107

ANDA 215107

SAGENT PHARMS INC

FDA Drug Application

Application #215107

Application Sponsors

ANDA 215107SAGENT PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/ML0CYANOCOBALAMINCYANOCOBALAMIN

FDA Submissions

UNKNOWN; ORIG1AP2022-11-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215107
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYANOCOBALAMIN","activeIngredients":"CYANOCOBALAMIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-15
        )

)

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