ANDA 203477

INTL MEDICATION SYS

FDA Drug Application

Application #203477

Application Sponsors

ANDA 203477

INTL MEDICATION SYS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

CALCIUM CHLORIDE 10%

CALCIUM CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

INTL MEDICATION SYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203477
            [companyName] => INTL MEDICATION SYS
            [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\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-09
        )

)