ANDA 211818

ZYDUS PHARMS USA INC

FDA Drug Application

Application #211818

Application Sponsors

ANDA 211818

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	CAPSULE;ORAL	100MG	0	DROXIDOPA	DROXIDOPA
002	CAPSULE;ORAL	200MG	0	DROXIDOPA	DROXIDOPA
003	CAPSULE;ORAL	300MG	0	DROXIDOPA	DROXIDOPA

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-05-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211818
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DROXIDOPA","activeIngredients":"DROXIDOPA","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)