NDA 021991

MERCK

FDA Drug Application

Application #021991

Documents

• Letter: 2006-10-13
• Letter: 2008-07-24
• Letter: 2011-06-17
• Letter: 2015-12-22
• Label: 2006-10-11
• Label: 2008-07-23
• Review: 2006-11-20
• Letter: 2011-11-17
• Letter: 2009-11-10
• Label: 2011-11-15
• Label: 2009-10-01
• Label: 2018-12-12
• Letter: 2018-12-20

Application Sponsors

NDA 021991

MERCK

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

1

ZOLINZA

VORINOSTAT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2006-10-06	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2011-11-14	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2009-09-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2013-04-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2015-10-07	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2015-12-17	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	4
SUPPL	6	Null	15
SUPPL	7	Null	14
SUPPL	8	Null	7
SUPPL	9	Null	7

CDER Filings

MSD SUB MERCK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21991
            [companyName] => MSD SUB MERCK
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLINZA","activeIngredients":"VORINOSTAT","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021991s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2011","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021991s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2009","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021991s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2008","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021991s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021991lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZOLINZA","submission":"VORINOSTAT","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-11
        )

)