ANDA 203451

INTL MEDICATION SYS

FDA Drug Application

Application #203451

Application Sponsors

ANDA 203451

INTL MEDICATION SYS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/ML

0

DEXTROSE 50%

DEXTROSE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

INTL MEDICATION SYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203451
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 50%","activeIngredients":"DEXTROSE","strength":"500MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-26
        )

)