ANDA 213071

NIVAGEN PHARMS INC

FDA Drug Application

Application #213071

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 213071

NIVAGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1GM/10ML (100MG/ML)

0

CALCIUM GLUCONATE

CALCIUM GLUCONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

NIVAGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213071
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCIUM GLUCONATE","submission":"CALCIUM GLUCONATE","actionType":"1GM\/10ML (100MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)