ANDA 212591

NIVAGEN PHARMS INC

FDA Drug Application

Application #212591

Application Sponsors

ANDA 212591

NIVAGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.2MG/ML

0

GLYCOPYRROLATE

GLYCOPYRROLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

NIVAGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212591
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-13
        )

)