ANDA 210500

HETERO LABS LTD III

FDA Drug Application

Application #210500

Documents

• Letter: 2019-03-13

Application Sponsors

ANDA 210500

HETERO LABS LTD III

Marketing Status

• None (Tentative Approval): 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

TA

2019-02-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210500
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/21\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210500Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-21
        )

)