ANDA 212253

NOVITIUM PHARMA

FDA Drug Application

Application #212253

Documents

• Letter: 2019-12-03

Application Sponsors

ANDA 212253

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	375MG	0	CHLORZOXAZONE	CHLORZOXAZONE
002	TABLET;ORAL	750MG	0	CHLORZOXAZONE	CHLORZOXAZONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212253
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212253Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-27
        )

)