ANDA 210130

MYLAN

FDA Drug Application

Application #210130

Documents

• Letter: 2019-05-21

Application Sponsors

ANDA 210130

MYLAN

Marketing Status

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

Application Products

001	TABLET, FOR SUSPENSION;ORAL	2MG	0	EVEROLIMUS	EVEROLIMUS
002	TABLET, FOR SUSPENSION;ORAL	3MG	0	EVEROLIMUS	EVEROLIMUS
003	TABLET, FOR SUSPENSION;ORAL	5MG	0	EVEROLIMUS	EVEROLIMUS

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2021-08-25	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210130
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"2MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"3MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"5MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210130Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-19
        )

)