ANDA 201536

APOTEX INC

FDA Drug Application

Application #201536

Application Sponsors

ANDA 201536

APOTEX INC

Marketing Status

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

Application Products

001	TABLET; ORAL	20MG	0	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE
002	TABLET; ORAL	40MG	0	ELETRIPTAN HYDROBROMIDE	ELETRIPTAN HYDROBROMIDE

FDA Submissions

ORIG

1

TA

2013-07-29

Submissions Property Types

ORIG

1

Null

19

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201536
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"40MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/29\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-07-29
        )

)