ANDA 212824

EUGIA PHARMA

FDA Drug Application

Application #212824

Application Sponsors

ANDA 212824

EUGIA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

0

MEDROXYPROGESTERONE ACETATE

MEDROXYPROGESTERONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212824
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDROXYPROGESTERONE ACETATE","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-22
        )

)