ANDA 215604

NOVITIUM PHARMA

FDA Drug Application

Application #215604

Application Sponsors

ANDA 215604

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	1.5MG	0	DEXAMETHASONE	DEXAMETHASONE
002	TABLET;ORAL	4MG	0	DEXAMETHASONE	DEXAMETHASONE
003	TABLET;ORAL	6MG	0	DEXAMETHASONE	DEXAMETHASONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215604
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-08
        )

)