ANDA 211575

NOVITIUM PHARMA

FDA Drug Application

Application #211575

Application Sponsors

ANDA 211575

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	2.5MG	0	PREDNISONE	PREDNISONE
002	TABLET;ORAL	5MG	0	PREDNISONE	PREDNISONE
003	TABLET;ORAL	10MG	0	PREDNISONE	PREDNISONE
004	TABLET;ORAL	20MG	0	PREDNISONE	PREDNISONE
005	TABLET;ORAL	50MG	0	PREDNISONE	PREDNISONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211575
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-15
        )

)