NDA 211530

HOSPIRA

FDA Drug Application

Application #211530

Documents

• Letter: 2019-02-13
• Label: 2022-12-16

Application Sponsors

NDA 211530

HOSPIRA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	SOLUTION;IV (INFUSION)	25MG/ML	0	BENDAMUSTINE	BENDAMUSTINE
002	SOLUTION;IV (INFUSION)	100MG/4ML	0	BENDAMUSTINE	BENDAMUSTINE
003	SOLUTION;IV (INFUSION)	200MG/8ML	0	BENDAMUSTINE	BENDAMUSTINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2019-01-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

HOSPIRA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211530
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE","activeIngredients":"BENDAMUSTINE","strength":"25MG\/ML","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE","activeIngredients":"BENDAMUSTINE","strength":"100MG\/4ML","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE","activeIngredients":"BENDAMUSTINE","strength":"200MG\/8ML","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/29\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211530Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-29
        )

)