ANDA 215908

TORRENT

FDA Drug Application

Application #215908

Application Sponsors

ANDA 215908

TORRENT

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	2MG	0	NITISINONE	NITISINONE
002	CAPSULE;ORAL	5MG	0	NITISINONE	NITISINONE
003	CAPSULE;ORAL	10MG	0	NITISINONE	NITISINONE
004	CAPSULE;ORAL	20MG	0	NITISINONE	NITISINONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215908
            [companyName] => TORRENT
            [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"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-09
        )

)