ANDA 215737

AKORN

FDA Drug Application

Application #215737

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 215737

AKORN

Marketing Status

• Prescription: 001

Application Products

001

POWDER;SUBCUTANEOUS

EQ 0.25MG BASE/VIAL

0

CETRORELIX ACETATE

CETRORELIX ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215737
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETRORELIX ACETATE","activeIngredients":"CETRORELIX ACETATE","strength":"EQ 0.25MG BASE\/VIAL","dosageForm":"POWDER;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-12
        )

)