FDA.report

Application 210493

Type
NDA
Sponsor
HELSINN HLTHCARE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001AKYNZEOFOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 235MG BASE;EQ 0.25MG BASEYesYes
002AKYNZEOFOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
69639-102AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-102AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-102AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-102AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-102AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-102AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-105AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-105AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-105AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-105AKYNZEOFosnetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent

Documents

DocumentSubmission typeDate
73532SUPPL 2023-04-14
73524SUPPL 2023-02-16
67696SUPPL2021-06-03
67685SUPPL2021-06-03
65106SUPPL2020-10-30
65084SUPPL2020-10-30
64206SUPPL2020-08-05
64205SUPPL2020-08-05
54390ORIG2018-05-31
53774ORIG2018-04-23
53747ORIG2018-04-20