BE PHARMS FDA Approval ANDA 213425

ANDA 213425

BE PHARMS

FDA Drug Application

Application #213425

Application Sponsors

ANDA 213425BE PHARMS

Marketing Status

Prescription001

Application Products

001POWDER;IV (INFUSION)350MG/VIAL0DAPTOMYCINDAPTOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

BE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213425
            [companyName] => BE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.