ANDA 211071

EUGIA PHARMA

FDA Drug Application

Application #211071

Application Sponsors

ANDA 211071

EUGIA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR

250MG/ML (250MG/ML)

0

HYDROXYPROGESTERONE CAPROATE

HYDROXYPROGESTERONE CAPROATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211071
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYPROGESTERONE CAPROATE","activeIngredients":"HYDROXYPROGESTERONE CAPROATE","strength":"250MG\/ML (250MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-16
        )

)