NDA 206302

ALLERGAN

FDA Drug Application

Application #206302

Documents

• Letter: 2016-06-06
• Label: 2016-06-06
• Review: 2016-09-12

Application Sponsors

NDA 206302

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 5MG BASE;80MG

1

BYVALSON

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2016-06-03

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206302
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BYVALSON","activeIngredients":"NEBIVOLOL HYDROCHLORIDE; VALSARTAN","strength":"EQ 5MG BASE;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/03\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206302s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206302s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206302Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/206302Orig1ByvalsonTOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-06-03
        )

)