ANDA 209525

TEVA PHARMS USA

FDA Drug Application

Application #209525

Documents

• Letter: 2020-08-24
• Letter: 2020-10-30

Application Sponsors

ANDA 209525

TEVA PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	500MG	0	ICOSAPENT ETHYL	ICOSAPENT ETHYL
002	CAPSULE;ORAL	1G	0	ICOSAPENT ETHYL	ICOSAPENT ETHYL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-06-05

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209525
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICOSAPENT ETHYL","activeIngredients":"ICOSAPENT ETHYL","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ICOSAPENT ETHYL","activeIngredients":"ICOSAPENT ETHYL","strength":"1G","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209525Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-05
        )

)