ANDA 205390

GLAND PHARMA LTD

FDA Drug Application

Application #205390

Application Sponsors

ANDA 205390

GLAND PHARMA LTD

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

UNKNOWN;	ORIG	1	AP	2016-05-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-07-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205390
            [companyName] => GLAND PHARMA LTD
            [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":"05\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/26\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-07-26
        )

)