ANDA 213914

SUN PHARM

FDA Drug Application

Application #213914

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 213914

SUN PHARM

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 12.5MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE
002	CAPSULE;ORAL	EQ 25MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE
003	CAPSULE;ORAL	EQ 37.5MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE
004	CAPSULE;ORAL	EQ 50MG BASE	0	SUNITINIB MALATE	SUNITINIB MALATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213914
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 12.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 37.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SUNITINIB MALATE","activeIngredients":"SUNITINIB MALATE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-16
        )

)