DR REDDYS LABS LTD FDA Approval NDA 215668

NDA 215668

DR REDDYS LABS LTD

FDA Drug Application

Application #215668

Documents

Letter2021-11-16

Application Sponsors

NDA 215668DR REDDYS LABS LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS100MG/4ML (25MG/ML)0BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1TA2021-11-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

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

)

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