FDA.reportPublic FDA data

Application 205648

Type
ANDA
Sponsor
QILU

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
60505-6193PalonosetronPalonosetron HydrochlorideApotex Corp.ANDACurrent
67184-0514PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0514PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0514PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0515PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0515PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0515PalonosetronPalonosetron HydrochlorideQilu Pharmaceutical Co., Ltd.ANDACurrent
68001-482PalonosetronPalonosetron HydrochlorideBluePoint LaboratoriesANDACurrent
68001-482PalonosetronPalonosetron HydrochlorideBluePoint LaboratoriesANDACurrent
68001-482PalonosetronPalonosetron HydrochlorideBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54154ORIG2018-05-11