ANDA 210123

GLAND PHARMA LTD

FDA Drug Application

Application #210123

Application Sponsors

ANDA 210123

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	500MG/10ML (50MG/ML)	0	FLUOROURACIL	FLUOROURACIL
002	INJECTABLE;INJECTION	1GM/20ML (50MG/ML)	0	FLUOROURACIL	FLUOROURACIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-27	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] => 210123
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"1GM\/20ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-27
        )

)