ANDA 210968

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210968

Application Sponsors

ANDA 210968

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

10MG/VIAL

0

OLANZAPINE

OLANZAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210968
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLANZAPINE","activeIngredients":"OLANZAPINE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-22
        )

)