FDA.reportPublic FDA data

Application 205718

Type
NDA
Sponsor
HELSINN HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AKYNZEONETUPITANT; PALONOSETRON HYDROCHLORIDECAPSULE;ORAL300MG;EQ 0.5MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69639-101AKYNZEONetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-101AKYNZEONetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-101AKYNZEONetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-101AKYNZEONetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-101AKYNZEONetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-101AKYNZEONetupitant and PalonosetronHelsinn Therapeutics (U.S.), Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67691SUPPL2021-06-03
67686SUPPL2021-06-03
19676SUPPL2015-05-06
19677SUPPL2015-05-04
32710SUPPL2015-04-29
24502ORIG2014-11-07
23000ORIG2014-11-07
19675ORIG2014-10-14
32709ORIG2014-10-10