ANDA 209348

DR REDDYS

FDA Drug Application

Application #209348

Documents

• Letter: 2021-11-02
• Letter: 2021-11-02

Application Sponsors

ANDA 209348

DR REDDYS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-10-14	STANDARD
UNKNOWN;	ORIG	2	TA	2021-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209348
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LENALIDOMIDE","submission":"LENALIDOMIDE","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)