FDA.reportPublic FDA data

Application 020789

Type
NDA
Sponsor
SUNOVION PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZONEGRANZONISAMIDECAPSULE;ORAL100MGYesYes
002ZONEGRANZONISAMIDECAPSULE;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ZONEGRANZONISAMIDECAPSULE;ORAL25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-680ZonegranZonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-680ZonegranzonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-680ZonegranZonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-680ZonegranZonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-681ZonegranZonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-681ZonegranzonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-681ZonegranZonisamideConcordia Pharmaceuticals Inc.NDACurrent
59212-681ZonegranZonisamideConcordia Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62563SUPPL2020-04-14
62558SUPPL2020-04-14
62557SUPPL2020-04-14
3378SUPPL2016-04-08
35380SUPPL2016-04-07
35375SUPPL2015-07-14
3373SUPPL2015-06-22
44073ORIG2012-02-03
13448SUPPL2012-01-31
25851SUPPL2012-01-30
35379SUPPL2011-09-29
25853SUPPL2011-09-27
3377SUPPL2011-05-31
25852SUPPL2010-04-21
3376SUPPL2010-04-21
35377SUPPL2010-04-20
13449SUPPL2010-04-20
23192ORIG2009-09-30
35378SUPPL2009-05-13
35376SUPPL2009-05-13
3375SUPPL2009-05-04
3374SUPPL2009-05-04
3372SUPPL2006-12-04
35374SUPPL2006-11-22
35373SUPPL2003-08-28
25850SUPPL2003-08-28
13447SUPPL2002-10-07
3371SUPPL2002-10-07
41708ORIG2000-03-27
25849ORIG2000-03-27
13446ORIG2000-03-27