ANDA 214267

SINTETICA SA

FDA Drug Application

Application #214267

Application Sponsors

ANDA 214267

SINTETICA SA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	1%	0	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	2%	0	LIDOCAINE HYDROCHLORIDE	LIDOCAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

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
        )

)