FDA.reportPublic FDA data

Application 022529

Type
NDA
Sponsor
EISAI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BELVIQLORCASERIN HYDROCHLORIDETABLET;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-529Belviqlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-529Belviqlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-529Belviqlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-529Belviqlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-529Belviqlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent
62856-529Belviqlorcaserin hydrochloride hemihydrateEisai Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48544SUPPL2017-05-26
48543SUPPL2017-05-26
48532SUPPL2017-05-25
48531SUPPL2017-05-25
38820SUPPL2016-04-04
29837SUPPL2014-12-11
42552ORIG2012-08-07
38819ORIG2012-06-27
29836ORIG2012-06-27