ANDA 209085

APOTEX INC

FDA Drug Application

Application #209085

Application Sponsors

ANDA 209085

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER;INTRAVENOUS

EQ 1GM BASE/VIAL

0

PEMETREXED DISODIUM

PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-09-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209085
            [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":"10\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-22
        )

)