ANDA 203774

APOTEX INC

FDA Drug Application

Application #203774

Application Sponsors

ANDA 203774

APOTEX INC

Marketing Status

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

Application Products

001	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM
002	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-04-24

Submissions Property Types

ORIG

1

Null

42

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203774
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-24
        )

)