ANDA 212784

AJANTA PHARMA LTD

FDA Drug Application

Application #212784

Application Sponsors

ANDA 212784

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 6MG BASE/ML

0

OSELTAMIVIR PHOSPHATE

OSELTAMIVIR PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212784
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-27
        )

)