ANDA 210965

EUGIA PHARMA

FDA Drug Application

Application #210965

Application Sponsors

ANDA 210965

EUGIA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PROGESTERONE

PROGESTERONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AO

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210965
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/04\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-04
        )

)