ANDA 204159

APOTEX INC

FDA Drug Application

Application #204159

Application Sponsors

ANDA 204159

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 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	2018-07-05
LABELING; Labeling	SUPPL	2	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204159
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"180MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/18\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-18
        )

)