BLA 761046

MERCK SHARP DOHME

FDA Drug Application

Application #761046

Documents

• Letter: 2016-10-25
• Label: 2016-10-28
• Review: 2016-12-09
• Summary Review: 2016-12-09

Application Sponsors

BLA 761046

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1000ML/40ML

0

ZINPLAVA

BEZLOTOXUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2016-10-21

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761046
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZINPLAVA","activeIngredients":"BEZLOTOXUMAB","strength":"1000ML\/40ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761046s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761046s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761046Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761046_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761046Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-10-21
        )

)