HONG KONG FDA Approval ANDA 214996

ANDA 214996

HONG KONG

FDA Drug Application

Application #214996

Application Sponsors

ANDA 214996HONG KONG

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION250MCG/0.5ML0GANIRELIX ACETATEGANIRELIX ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2022-06-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

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
        )

)

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