ANDA 211553

MEDEFIL INC

FDA Drug Application

Application #211553

Application Sponsors

ANDA 211553

MEDEFIL INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

CALCIUM CHLORIDE 10%

CALCIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MEDEFIL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211553
            [companyName] => MEDEFIL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM CHLORIDE 10%","activeIngredients":"CALCIUM CHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-01
        )

)