ANDA 207934

PAR PHARM

FDA Drug Application

Application #207934

Documents

• Letter: 2020-03-18

Application Sponsors

ANDA 207934

PAR PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	2.5MG	0	EVEROLIMUS	EVEROLIMUS
002	TABLET;ORAL	5MG	0	EVEROLIMUS	EVEROLIMUS
003	TABLET;ORAL	7.5MG	0	EVEROLIMUS	EVEROLIMUS
004	TABLET;ORAL	10MG	0	EVEROLIMUS	EVEROLIMUS

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-09	STANDARD
UNKNOWN;	ORIG	2	TA	2019-12-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207934
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207934Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-09
        )

)