ANDA 208086

AMPHASTAR PHARMS INC

FDA Drug Application

Application #208086

Documents

• Letter: 2021-01-12

Application Sponsors

ANDA 208086

AMPHASTAR PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/VIAL

0

GLUCAGON

GLUCAGON

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AMPHASTAR PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208086
            [companyName] => AMPHASTAR PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLUCAGON","activeIngredients":"GLUCAGON","strength":"1MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-28
        )

)