NDA 210661

APOTEX INC

FDA Drug Application

Application #210661

Documents

• Letter: 2018-03-29

Application Sponsors

NDA 210661

APOTEX INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	100MG	0	PEMETREXED	PEMETREXED
002	INJECTABLE;INJECTION	500MG	0	PEMETREXED	PEMETREXED

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

TA

2018-03-28

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210661
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210661Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-28
        )

)