ANDA 202159

EUROHLTH INTL SARL

FDA Drug Application

Application #202159

Documents

• Letter: 2018-05-11

Application Sponsors

ANDA 202159

EUROHLTH INTL SARL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-27

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

EUROHLTH INTL SARL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202159
            [companyName] => EUROHLTH INTL SARL
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202159Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-27
        )

)