NDA 212209

SLAYBACK PHARMA LLC

FDA Drug Application

Application #212209

Documents

• Letter: 2020-07-06
• Label: 2022-12-09

Application Sponsors

NDA 212209

SLAYBACK PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100 mg/m2

0

BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2020-07-02

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SLAYBACK PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212209
            [companyName] => SLAYBACK PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100 mg\/m2","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2020","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\\\/2020\\\/212209Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)