ANDA 206413

IDT AUSTRALIA LTD

FDA Drug Application

Application #206413

Application Sponsors

ANDA 206413

IDT AUSTRALIA LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	CAPSULE;ORAL	5MG	0	TEMOZOLOMIDE	TEMOZOLOMIDE
002	CAPSULE;ORAL	20MG	0	TEMOZOLOMIDE	TEMOZOLOMIDE
003	CAPSULE;ORAL	100MG	0	TEMOZOLOMIDE	TEMOZOLOMIDE
004	CAPSULE;ORAL	140MG	0	TEMOZOLOMIDE	TEMOZOLOMIDE
005	CAPSULE;ORAL	180MG	0	TEMOZOLOMIDE	TEMOZOLOMIDE
006	CAPSULE;ORAL	250MG	0	TEMOZOLOMIDE	TEMOZOLOMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-04-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

CHARTWELL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206413
            [companyName] => CHARTWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"180MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-29
        )

)