ANDA 210721

APOTEX

FDA Drug Application

Application #210721

Application Sponsors

ANDA 210721

APOTEX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	25MG	0	CYCLOSPORINE	CYCLOSPORINE
002	CAPSULE;ORAL	50MG	0	CYCLOSPORINE	CYCLOSPORINE
003	CAPSULE;ORAL	100MG	0	CYCLOSPORINE	CYCLOSPORINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210721
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/10\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-10
        )

)