ANDA 202103

APOTEX INC

FDA Drug Application

Application #202103

Documents

• Letter: 2016-06-14
• Review: 2020-03-19

Application Sponsors

ANDA 202103

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	20MG	0	DASATINIB	DASATINIB
002	TABLET;ORAL	50MG	0	DASATINIB	DASATINIB
003	TABLET;ORAL	70MG	0	DASATINIB	DASATINIB
004	TABLET;ORAL	100MG	0	DASATINIB	DASATINIB

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2016-06-10
LABELING; Labeling	SUPPL	2	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-01-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-01-03	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202103
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"70MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202103Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/202103Orig1s000BioeqR.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-10
        )

)