ANDA 214996

HONG KONG

FDA Drug Application

Application #214996

Application Sponsors

ANDA 214996

HONG KONG

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MCG/0.5ML

0

GANIRELIX ACETATE

GANIRELIX ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HONG KONG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214996
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANIRELIX ACETATE","activeIngredients":"GANIRELIX ACETATE","strength":"250MCG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-06
        )

)