ANDA 211041

NOVITIUM PHARMA

FDA Drug Application

Application #211041

Documents

• Letter: 2019-09-27

Application Sponsors

ANDA 211041

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	2MG	0	NITISINONE	NITISINONE
002	CAPSULE;ORAL	5MG	0	NITISINONE	NITISINONE
003	CAPSULE;ORAL	10MG	0	NITISINONE	NITISINONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211041
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211041Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-26
        )

)