ANDA 213265

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213265

Application Sponsors

ANDA 213265

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 60MG BASE

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213265
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-10
        )

)