ANDA 078274

SAGENT PHARMS INC

FDA Drug Application

Application #078274

Application Sponsors

ANDA 078274

SAGENT PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	10MG/VIAL	0	VECURONIUM BROMIDE	VECURONIUM BROMIDE
002	INJECTABLE;INJECTION	20MG/VIAL	0	VECURONIUM BROMIDE	VECURONIUM BROMIDE

FDA Submissions

	ORIG	1	AP	2008-12-29
LABELING; Labeling	SUPPL	4	AP	2018-07-26	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78274
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VECURONIUM BROMIDE","submission":"VECURONIUM BROMIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VECURONIUM BROMIDE","submission":"VECURONIUM BROMIDE","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)