ANDA 210480

LOTUS PHARM CO LTD

FDA Drug Application

Application #210480

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 210480

LOTUS PHARM CO LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

001	CAPSULE;ORAL	2.5MG	0	LENALIDOMIDE	LENALIDOMIDE
002	CAPSULE;ORAL	5MG	0	LENALIDOMIDE	LENALIDOMIDE
003	CAPSULE;ORAL	10MG	0	LENALIDOMIDE	LENALIDOMIDE
004	CAPSULE;ORAL	15MG	0	LENALIDOMIDE	LENALIDOMIDE
005	CAPSULE;ORAL	20MG	0	LENALIDOMIDE	LENALIDOMIDE
006	CAPSULE;ORAL	25MG	0	LENALIDOMIDE	LENALIDOMIDE

FDA Submissions

UNKNOWN;	ORIG	1	TA	2020-09-24	STANDARD
UNKNOWN;	ORIG	2	TA	2022-08-31	STANDARD

Submissions Property Types

ORIG	1	Null	31
ORIG	2	Null	31

TE Codes

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

CDER Filings

LOTUS PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210480
            [companyName] => LOTUS PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-24
        )

)