ANDA 211040

NOVITIUM PHARMA

FDA Drug Application

Application #211040

Documents

• Letter: 2019-02-21

Application Sponsors

ANDA 211040

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

SIROLIMUS

SIROLIMUS

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-05-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AA

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211040
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIROLIMUS","activeIngredients":"SIROLIMUS","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211040Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-28
        )

)