ANDA 210708

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210708

Application Sponsors

ANDA 210708

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210708
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-15
        )

)