ANDA 208927

BIOCON LTD

FDA Drug Application

Application #208927

Application Sponsors

ANDA 208927

BIOCON LTD

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

UNKNOWN;

ORIG

1

TA

2018-05-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

BIOCON LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208927
            [companyName] => BIOCON LTD
            [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":"05\/04\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-04
        )

)