ANDA 203609

SAGENT PHARMS INC

FDA Drug Application

Application #203609

Application Sponsors

ANDA 203609

SAGENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	2.5GM/50ML (50MG/ML)	0	FLUOROURACIL	FLUOROURACIL
002	INJECTABLE;INJECTION	5GM/100ML (50MG/ML)	0	FLUOROURACIL	FLUOROURACIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-02-17
LABELING; Labeling	SUPPL	2	AP	2016-11-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203609
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"2.5GM\/50ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"5GM\/100ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/17\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/14\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-11-14
        )

)