SINTETICA SA FDA Approval ANDA 214267

ANDA 214267

SINTETICA SA

FDA Drug Application

Application #214267

Application Sponsors

ANDA 214267SINTETICA SA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION1%0LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE
002INJECTABLE;INJECTION2%0LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

SINTETICA SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214267
            [companyName] => SINTETICA SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-19
        )

)

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