ANDA 212750

GRANULES

FDA Drug Application

Application #212750

Application Sponsors

ANDA 212750

GRANULES

Marketing Status

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

Application Products

001	CAPSULE;ORAL	0.125MG	0	DOFETILIDE	DOFETILIDE
002	CAPSULE;ORAL	0.25MG	0	DOFETILIDE	DOFETILIDE
003	CAPSULE;ORAL	0.5MG	0	DOFETILIDE	DOFETILIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

GRANULES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212750
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOFETILIDE","activeIngredients":"DOFETILIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-14
        )

)