ANDA 204696

SAGENT PHARMS INC

FDA Drug Application

Application #204696

Application Sponsors

ANDA 204696

SAGENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	200MG/100ML (2MG/ML)	0	LINEZOLID	LINEZOLID
002	SOLUTION;INTRAVENOUS	600MG/300ML (2MG/ML)	0	LINEZOLID	LINEZOLID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-06-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204696
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LINEZOLID","activeIngredients":"LINEZOLID","strength":"600MG\/300ML (2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/28\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-28
        )

)