ANDA 210154

ZYDUS PHARMS USA INC

FDA Drug Application

Application #210154

Documents

• Letter: 2022-09-13

Application Sponsors

ANDA 210154

ZYDUS PHARMS USA INC

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	2021-08-16	STANDARD
UNKNOWN;	ORIG	2	TA	2022-09-12	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

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210154
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-16
        )

)