ANDA 212254

NOVITIUM PHARMA

FDA Drug Application

Application #212254

Application Sponsors

ANDA 212254

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

CHLORZOXAZONE

CHLORZOXAZONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212254
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-12
        )

)