ANDA 209851

APOTEX INC

FDA Drug Application

Application #209851

Application Sponsors

ANDA 209851

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER;INTRAVENOUS

EQ 750MG BASE/VIAL

0

PEMETREXED DISODIUM

PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-08-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209851
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE; IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-25
        )

)