ANDA 212390

DIPHARMA

FDA Drug Application

Application #212390

Application Sponsors

ANDA 212390

DIPHARMA

Marketing Status

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

Application Products

001	CAPSULE;ORAL	2MG	0	NITISINONE	NITISINONE
002	CAPSULE;ORAL	5MG	0	NITISINONE	NITISINONE
003	CAPSULE;ORAL	10MG	0	NITISINONE	NITISINONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

DIPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212390
            [companyName] => DIPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)