ANDA 214896

RUBICON

FDA Drug Application

Application #214896

Application Sponsors

ANDA 214896

RUBICON

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	0	PRIMIDONE	PRIMIDONE
002	TABLET;ORAL	250MG	0	PRIMIDONE	PRIMIDONE
003	TABLET;ORAL	125MG	0	PRIMIDONE	PRIMIDONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214896
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRIMIDONE","activeIngredients":"PRIMIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRIMIDONE","activeIngredients":"PRIMIDONE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-28
        )

)