ANDA 210385

AUROBINDO PHARMA USA

FDA Drug Application

Application #210385

Documents

• Letter: 2018-09-07

Application Sponsors

ANDA 210385

AUROBINDO PHARMA USA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 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

TA

2018-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210385
            [companyName] => AUROBINDO PHARMA USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"120MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"240MG","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210385Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-17
        )

)