ANDA 204639

CHEMI SPA

FDA Drug Application

Application #204639

Application Sponsors

ANDA 204639

CHEMI SPA

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	2016-11-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-01-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

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

CDER Filings

CHEMI SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204639
            [companyName] => CHEMI SPA
            [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":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/13\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-13
        )

)