ANDA 210124

GLAND PHARMA LTD

FDA Drug Application

Application #210124

Application Sponsors

ANDA 210124

GLAND PHARMA LTD

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	2017-12-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-09-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210124
            [companyName] => GLAND PHARMA LTD
            [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":"12\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-26
        )

)