ANDA 211880

INTL MEDICATION SYS

FDA Drug Application

Application #211880

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 211880

INTL MEDICATION SYS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

EQ 30MG BASE/30ML (EQ 1MG BASE/ML)

0

EPINEPHRINE

EPINEPHRINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

INTL MEDICATION SYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211880
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"EQ 30MG BASE\/30ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211880Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-24
        )

)