ANDA 210435

CIPLA

FDA Drug Application

Application #210435

Application Sponsors

ANDA 210435

CIPLA

Marketing Status

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

Application Products

001	CAPSULE;ORAL	5MG	0	LENALIDOMIDE	LENALIDOMIDE
002	CAPSULE;ORAL	10MG	0	LENALIDOMIDE	LENALIDOMIDE
003	CAPSULE;ORAL	15MG	0	LENALIDOMIDE	LENALIDOMIDE
004	CAPSULE;ORAL	25MG	0	LENALIDOMIDE	LENALIDOMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2022-09-06	STANDARD
UNKNOWN;	ORIG	2	TA	2022-09-06	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

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210435
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)