NDA 215668

DR REDDYS LABS LTD

FDA Drug Application

Application #215668

Documents

• Letter: 2021-11-16

Application Sponsors

NDA 215668

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

100MG/4ML (25MG/ML)

0

BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2021-11-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215668
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)