ANDA 210531

MYLAN

FDA Drug Application

Application #210531

Documents

• Letter: 2020-09-18

Application Sponsors

ANDA 210531

MYLAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED RELEASE;ORAL	120MG	0	DIMETHYL FUMARATE	DIMETHYL FUMARATE
002	CAPSULE, DELAYED RELEASE;ORAL	240MG	0	DIMETHYL FUMARATE	DIMETHYL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210531
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"120MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"240MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-17
        )

)