NDA 211090

BIOCON PHARMA LTD

FDA Drug Application

Application #211090

Application Sponsors

NDA 211090

BIOCON PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

POWDER;INTRAVENOUS

EQ 100MG BASE/VIAL

0

PEMETREXED DISODIUM

PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-05-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AP

CDER Filings

BIOCON PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211090
            [companyName] => BIOCON PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/23\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-23
        )

)