NDA 206510

MERCK SHARP DOHME

FDA Drug Application

Application #206510

Documents

• Letter: 2015-02-12
• Review: 2016-04-11
• Label: 2015-02-10
• Summary Review: 2016-04-11
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 206510

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

150MG;EQ 300MG BASE

0

DUTREBIS

LAMIVUDINE; RALTEGRAVIR POTASSIUM

FDA Submissions

TYPE 4; Type 4 - New Combination

ORIG

1

AP

2015-02-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206510
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTREBIS","activeIngredients":"LAMIVUDINE; RALTEGRAVIR POTASSIUM","strength":"150MG;EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/06\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206510lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/06\/2015","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\\\/2015\\\/206510lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206510Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206510Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206510Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-02-06
        )

)