ANDA 213500

CROSSMEDIKA SA

FDA Drug Application

Application #213500

Documents

• Letter: 2020-08-24

Application Sponsors

ANDA 213500

CROSSMEDIKA SA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	150MG	0	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE
002	CAPSULE;ORAL	200MG	0	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE
003	CAPSULE;ORAL	250MG	0	MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CROSSMEDIKA SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213500
            [companyName] => CROSSMEDIKA SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEXILETINE HYDROCHLORIDE","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEXILETINE HYDROCHLORIDE","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEXILETINE HYDROCHLORIDE","activeIngredients":"MEXILETINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-22
        )

)