ANDA 210249

EUGIA PHARMA

FDA Drug Application

Application #210249

Documents

• Letter: 2020-11-04

Application Sponsors

ANDA 210249

EUGIA PHARMA

Marketing Status

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

Application Products

001	CAPSULE;ORAL	1MG	0	POMALIDOMIDE	POMALIDOMIDE
002	CAPSULE;ORAL	2MG	0	POMALIDOMIDE	POMALIDOMIDE
003	CAPSULE;ORAL	3MG	0	POMALIDOMIDE	POMALIDOMIDE
004	CAPSULE;ORAL	4MG	0	POMALIDOMIDE	POMALIDOMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-10-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-05-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-05-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

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

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210249
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210249Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-30
        )

)