ANDA 215560

NOVITIUM PHARMA

FDA Drug Application

Application #215560

Application Sponsors

ANDA 215560

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG;25MG	0	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE
002	TABLET;ORAL	100MG;25MG	0	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-25

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] => 215560
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"50MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-25
        )

)