AMPHASTAR PHARMS INC FDA Approval ANDA 212613

ANDA 212613

AMPHASTAR PHARMS INC

FDA Drug Application

Application #212613

Application Sponsors

ANDA 212613AMPHASTAR PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION250MCG/0.5ML0GANIRELIX ACETATEGANIRELIX ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

AMPHASTAR PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212613
            [companyName] => AMPHASTAR PHARMS INC
            [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":"04\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-07
        )

)

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