ANDA 207585

AUROBINDO PHARMA

FDA Drug Application

Application #207585

Application Sponsors

ANDA 207585

AUROBINDO PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;0.4MG

0

RHUZDAH

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207585
            [companyName] => AUROBINDO PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RHUZDAH","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;0.4MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-11
        )

)