ANDA 206133

HIKMA

FDA Drug Application

Application #206133

Documents

• Letter: 2018-05-11

Application Sponsors

ANDA 206133

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	0.25MG	0	EVEROLIMUS	EVEROLIMUS
002	TABLET;ORAL	0.5MG	0	EVEROLIMUS	EVEROLIMUS
003	TABLET;ORAL	0.75MG	0	EVEROLIMUS	EVEROLIMUS
004	TABLET;ORAL	1MG	0	EVEROLIMUS	EVEROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206133
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206133Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-12
        )

)