ANDA 215041

NOVITIUM PHARMA

FDA Drug Application

Application #215041

Application Sponsors

ANDA 215041

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

150MG

0

RIFABUTIN

RIFABUTIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215041
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIFABUTIN","activeIngredients":"RIFABUTIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-17
        )

)