FDA.reportPublic FDA data

Application 022275

Type
NDA
Sponsor
OTSUKA AMERICA PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAMSCATOLVAPTANTABLET;ORAL15MGYesNo
002SAMSCATOLVAPTANTABLET;ORAL30MGYesYes
003SAMSCATOLVAPTANTABLET;ORAL60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-020SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-020SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-020SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-020SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-020SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-020SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-021SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-021SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-021SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-021SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-021SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-021SAMSCAtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
60505-4704TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4704TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4704TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4704TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4705TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4705TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4705TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4705TOLVAPTANtolvaptanApotex Corp.NDACurrent
60505-4705TOLVAPTANtolvaptanApotex Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67163SUPPL2021-04-23
67162SUPPL2021-04-23
53807SUPPL2018-04-24
53796SUPPL2018-04-24
53795SUPPL2018-04-24
48642SUPPL2017-06-05
48624SUPPL2017-06-01
29511SUPPL2014-03-05
17185SUPPL2014-03-04
23705ORIG2013-12-27
38485SUPPL2013-05-21
7156SUPPL2013-05-08
29510SUPPL2013-04-18
17184SUPPL2013-04-16
29509SUPPL2012-11-19
17183SUPPL2012-11-19
7155SUPPL2012-09-17
7154SUPPL2012-02-03
38484SUPPL2012-02-02
29508SUPPL2011-09-28
24272ORIG2009-07-21
21977ORIG2009-07-21
29507ORIG2009-05-27
17182ORIG2009-05-25