ANDA 214269

SINTETICA SA

FDA Drug Application

Application #214269

Application Sponsors

ANDA 214269

SINTETICA SA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

SINTETICA SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214269
            [companyName] => SINTETICA SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"4%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-05
        )

)