ANDA 212613

AMPHASTAR PHARMS INC

FDA Drug Application

Application #212613

Application Sponsors

ANDA 212613

AMPHASTAR PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MCG/0.5ML

0

GANIRELIX ACETATE

GANIRELIX ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

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
        )

)