ANDA 211121

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211121

Application Sponsors

ANDA 211121

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

25MG/10ML (2.5MG/ML)

0

NICARDIPINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211121
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICARDIPINE HYDROCHLORIDE","activeIngredients":"NICARDIPINE HYDROCHLORIDE","strength":"25MG\/10ML (2.5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-08
        )

)