ANDA 213803

TEVA PHARMS USA

FDA Drug Application

Application #213803

Application Sponsors

ANDA 213803

TEVA PHARMS USA

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

2021-11-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213803
            [companyName] => TEVA PHARMS USA
            [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":"11\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-30
        )

)