FDA.reportPublic FDA data

Application 211801

Type
NDA
Sponsor
ARDELYX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBSRELATENAPANOR HYDROCHLORIDETABLET;ORALEQ 50MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73154-050IBSRELAtenapanor hydrochlorideArdelyx, Inc.NDACurrent
73154-050IBSRELAtenapanor hydrochlorideArdelyx, Inc.NDACurrent
73154-050IBSRELAtenapanor hydrochlorideArdelyx, Inc.NDACurrent
73154-050IBSRELAtenapanor hydrochlorideArdelyx, Inc.NDACurrent
73154-050IBSRELAtenapanor hydrochlorideArdelyx, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82222SUPPL 2025-05-21
82236SUPPL 2025-05-20
82235SUPPL 2025-05-20
80844SUPPL 2025-01-13
80843SUPPL 2025-01-13
80839SUPPL 2025-01-13
70715SUPPL2022-04-06
70714SUPPL2022-04-06
70708SUPPL2022-04-06
68864SUPPL2021-10-04
68780SUPPL2021-09-24
67565SUPPL2021-05-20
67562SUPPL2021-05-20
66514SUPPL2021-03-09
60558ORIG2019-10-15
59991ORIG2019-09-13
59990ORIG2019-09-12
59989ORIG2019-09-12