ANDA 216331

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216331

Application Sponsors

ANDA 216331

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/5ML

0

ACYCLOVIR

ACYCLOVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216331
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"200MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACYCLOVIR","submission":"ACYCLOVIR","actionType":"200MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)