FDA.reportPublic FDA data

Application 204731

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INJECTION0.25MG(BASE)/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 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