ANDA 211676

NOVITIUM PHARMA

FDA Drug Application

Application #211676

Documents

• Letter: 2019-10-03

Application Sponsors

ANDA 211676

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	1GM/10ML	0	LEVOCARNITINE	LEVOCARNITINE
002	SOLUTION;ORAL	1GM/10ML	0	LEVOCARNITINE SF	LEVOCARNITINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211676
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCARNITINE","activeIngredients":"LEVOCARNITINE","strength":"1GM\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOCARNITINE SF","activeIngredients":"LEVOCARNITINE","strength":"1GM\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211676Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-14
        )

)