ANDA 216796

AUROBINDO PHARMA

FDA Drug Application

Application #216796

Application Sponsors

ANDA 216796

AUROBINDO PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.35MG

0

EMZAHH

NORETHINDRONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB2

CDER Filings

AUROBINDO PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216796
            [companyName] => AUROBINDO PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMZAHH","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-06
        )

)