ANDA 204890

QILU PHARM CO LTD

FDA Drug Application

Application #204890

Application Sponsors

ANDA 204890

QILU PHARM CO LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	INJECTABLE;IV (INFUSION)	EQ 100MG BASE/1VILE	0	PEMETREXED	PEMETREXED
002	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	0	PEMETREXED	PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-05-19

Submissions Property Types

ORIG

1

Null

42

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

QILU PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204890
            [companyName] => QILU PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"EQ 100MG BASE\/1VILE","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-19
        )

)