FDA.reportPublic FDA data

Application 021372

Type
NDA
Sponsor
HELSINN HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALOXIPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)YesYes
002ALOXIPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-365palonosetron hydrochloridepalonosetron hydrochlorideAccord Healthcare, Inc.NDA AUTHORIZED GENERICCurrent
16729-365palonosetron hydrochloridepalonosetron hydrochlorideAccord Healthcare, Inc.NDA AUTHORIZED GENERICCurrent
16729-365palonosetron hydrochloridepalonosetron hydrochlorideAccord Healthcare, Inc.NDA AUTHORIZED GENERICCurrent
62856-797Aloxipalonosetron hydrochlorideEisai Inc.NDACurrent
62856-797Aloxipalonosetron hydrochlorideEisai Inc.NDACurrent
62856-798Aloxipalonosetron hydrochlorideEisai Inc.NDACurrent
62856-798Aloxipalonosetron hydrochlorideEisai Inc.NDACurrent
69097-927palonosetron hydrochloridepalonosetron hydrochlorideCipla USA Inc.NDA AUTHORIZED GENERICCurrent
69097-927palonosetron hydrochloridepalonosetron hydrochlorideCipla USA Inc.NDA AUTHORIZED GENERICCurrent
69097-927palonosetron hydrochloridepalonosetron hydrochlorideCipla USA Inc.NDA AUTHORIZED GENERICCurrent
69639-103Aloxipalonosetron hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-103Aloxipalonosetron hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent
69639-103Aloxipalonosetron hydrochlorideHelsinn Therapeutics (U.S.), Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62422SUPPL2020-04-02
62419SUPPL2020-04-02
5218SUPPL2014-09-23
15338SUPPL2014-09-22
27629SUPPL2014-06-02
5217SUPPL2014-06-02
15337SUPPL2014-05-28
27628SUPPL2014-02-11
36794SUPPL2014-02-07
44641SUPPL2009-12-12
42126SUPPL2009-12-12
24195SUPPL2009-12-12
21627SUPPL2009-12-12
36793SUPPL2008-03-05
15336SUPPL2008-03-05
5216SUPPL2008-03-05
5215SUPPL2008-03-05
27627SUPPL2007-09-04
15335SUPPL2007-09-04
5214SUPPL2006-09-18
36792SUPPL2006-08-29
5213SUPPL2005-07-08
15334SUPPL2005-07-07
21626ORIG2004-01-15
36791ORIG2003-08-06
27626ORIG2003-08-06
64037ORIG1900-01-01
64036ORIG1900-01-01
64035ORIG1900-01-01
64034ORIG1900-01-01
58110SUPPL1900-01-01
51540SUPPL1900-01-01
51539SUPPL1900-01-01
51538SUPPL1900-01-01
51537SUPPL1900-01-01