ANDA 215336

AMNEAL

FDA Drug Application

Application #215336

Application Sponsors

ANDA 215336

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/0.2ML

0

LEUPROLIDE ACETATE

LEUPROLIDE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215336
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUPROLIDE ACETATE","activeIngredients":"LEUPROLIDE ACETATE","strength":"1MG\/0.2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-28
        )

)