ANDA 208597

MYLAN

FDA Drug Application

Application #208597

Application Sponsors

ANDA 208597

MYLAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	60MG	0	TICAGRELOR	TICAGRELOR
002	TABLET;ORAL	90MG	0	TICAGRELOR	TICAGRELOR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-07-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208597
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TICAGRELOR","activeIngredients":"TICAGRELOR","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)