ANDA 210696

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210696

Application Sponsors

ANDA 210696

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

10MG/ML (10MG/ML)

0

PHENYLEPHRINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP2

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210696
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"10MG\/ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYLEPHRINE HYDROCHLORIDE","submission":"PHENYLEPHRINE HYDROCHLORIDE","actionType":"10MG\/ML (10MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)