NDA 216078

CELERITY PHARMS

FDA Drug Application

Application #216078

Documents

• Letter: 2022-07-15
• Label: 2022-12-16

Application Sponsors

NDA 216078

CELERITY PHARMS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;IV (INFUSION)

100MG/4ML

0

BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2022-07-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

CELERITY PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216078
            [companyName] => CELERITY PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/4ML","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2022","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\\\/2022\\\/216078Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-14
        )

)