FDA.reportPublic FDA data

Application 208109

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208109-001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)SOLUTION / INTRAVENOUSRLD2017-11-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208109-001PALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)SOLUTION / INTRAVENOUSRLD2017-11-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalonosetronPALONOSETRON HYDROCHLORIDEBLuePoint Laboratoriesbb2be46a-56f7-48b6-bb05-3c6b12c8b1ea2026-07-06Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEEugia US LLC42e2d437-0712-4e9c-9c2a-00093c406d622025-10-30Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.4af600d1-0ab1-41c5-af2f-9dc24cf3c90e2025-06-09Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
PalonosetronPALONOSETRON HYDROCHLORIDEApotex Corp.903d7aba-277e-6d28-4fee-fd2d605ab6a92025-01-02Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEAvenacy, Inc.0063b66a-a71b-473c-97b8-7c59f2a5b18e2024-05-15Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Inc5bfb3984-2b47-4e06-9bbb-d055ebc376c82024-02-05Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDESandoz Incaff1505c-8d34-46e6-9559-c5b1128878752024-02-05Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMeitheal Pharmaceuticals Inc.11bb07b2-6530-45ab-a916-ba9dd3107fc32023-08-17Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDECipla USA Inc.37e7ef89-fd77-44e0-9271-ae91f88226032022-01-13Warnings, Adverse reactionsName fallback
brand name: palonosetron hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
PalonosetronPALONOSETRON HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.633abdc2-a942-4eb2-a0f8-f9f4e727211e2021-10-18Warnings, Adverse reactionsName fallback
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEBaxter Healthcare Corporation0f3bfe3d-75c8-42eb-84be-570f8e251fdd2020-09-15Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEMylan Institutional LLC0a781796-bb74-4c5f-8d26-9ce520b818f72020-06-09Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDESagent Pharmaceuticals6e60d03d-eae6-4924-a507-e77ea077c1ab2020-04-28Warnings, Adverse reactionsName fallback
brand name: palonosetron hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE
Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDETeva Parenteral Medicines, Inc.911783eb-91a8-4ef4-bd6f-809211e207d62020-04-01Warnings, Adverse reactionsName fallback
brand name: Palonosetron Hydrochloride
generic name: PALONOSETRON HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-942PalonosetronPalonosetronFresenius Kabi USA, LLCNDACurrent
63323-942PalonosetronPalonosetronFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56644SUPPL2019-07-15
50501ORIG2018-12-20
56667SUPPL2018-12-07
55854ORIG2018-10-09
50469ORIG2017-11-22