HONG KONG FDA Approval ANDA 213786

ANDA 213786

HONG KONG

FDA Drug Application

Application #213786

Application Sponsors

ANDA 213786HONG KONG

Marketing Status

Prescription001

Application Products

001POWDER;IV (INFUSION)350MG/VIAL0DAPTOMYCINDAPTOMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2021-06-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HONG KONG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213786
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-29
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.