FDA.reportPublic FDA data

Application 208524

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BELVIQ XRLORCASERIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-535BELVIQ XRlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-535BELVIQ XRlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-535BELVIQ XRlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-535BELVIQ XRlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-535BELVIQ XRlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-535BELVIQ XRlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48545SUPPL2017-05-26
48530SUPPL2017-05-25
46039ORIG2016-10-26
46038ORIG2016-10-26
32911ORIG2016-07-19
40636ORIG2016-07-18