ANDA 210538

ZYDUS PHARMS USA INC

FDA Drug Application

Application #210538

Documents

• Letter: 2020-02-21

Application Sponsors

ANDA 210538

ZYDUS PHARMS USA INC

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

2019-11-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210538
            [companyName] => ZYDUS PHARMS
            [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":"09\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-24
        )

)