Home Applications 207963 Application 207963
Type NDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207963-001 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) SOLUTION / INTRAVENOUS 2016-08-22
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.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N207963-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) SOLUTION / INTRAVENOUS 2016-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207963-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) SOLUTION / INTRAVENOUS 2016-08-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207963-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) SOLUTION / INTRAVENOUS 2016-08-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N207963-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) SOLUTION / INTRAVENOUS 2016-08-22 a50c72e98297…
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 · 12 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Palonosetron PALONOSETRON HYDROCHLORIDE BLuePoint Laboratories bb2be46a-56f7-48b6-bb05-3c6b12c8b1ea 2026-07-06 Warnings, Adverse reactions Name fallback generic name: PALONOSETRON HYDROCHLORIDE Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE Eugia US LLC 42e2d437-0712-4e9c-9c2a-00093c406d62 2025-10-30 Warnings, Adverse reactions Name fallback brand name: Palonosetron Hydrochloride generic name: PALONOSETRON HYDROCHLORIDE Palonosetron PALONOSETRON HYDROCHLORIDE Apotex Corp. 4af600d1-0ab1-41c5-af2f-9dc24cf3c90e 2025-06-09 Warnings, Adverse reactions Name fallback generic name: PALONOSETRON HYDROCHLORIDE Palonosetron PALONOSETRON HYDROCHLORIDE Apotex Corp. 903d7aba-277e-6d28-4fee-fd2d605ab6a9 2025-01-02 Warnings, Adverse reactions Name fallback generic name: PALONOSETRON HYDROCHLORIDE Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE Sandoz Inc aff1505c-8d34-46e6-9559-c5b112887875 2024-02-05 Warnings, Adverse reactions Name fallback brand name: Palonosetron Hydrochloride generic name: PALONOSETRON HYDROCHLORIDE Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE Meitheal Pharmaceuticals Inc. 11bb07b2-6530-45ab-a916-ba9dd3107fc3 2023-08-17 Warnings, Adverse reactions Name fallback brand name: Palonosetron Hydrochloride generic name: PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride PALONOSETRON HYDROCHLORIDE Cipla USA Inc. 37e7ef89-fd77-44e0-9271-ae91f8822603 2022-01-13 Warnings, Adverse reactions Name fallback brand name: palonosetron hydrochloride generic name: PALONOSETRON HYDROCHLORIDE Palonosetron PALONOSETRON HYDROCHLORIDE Qilu Pharmaceutical Co., Ltd. 633abdc2-a942-4eb2-a0f8-f9f4e727211e 2021-10-18 Warnings, Adverse reactions Name fallback generic name: PALONOSETRON HYDROCHLORIDE Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE Baxter Healthcare Corporation 0f3bfe3d-75c8-42eb-84be-570f8e251fdd 2020-09-15 Warnings, Adverse reactions Name fallback brand name: Palonosetron Hydrochloride generic name: PALONOSETRON HYDROCHLORIDE Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE Mylan Institutional LLC 0a781796-bb74-4c5f-8d26-9ce520b818f7 2020-06-09 Warnings, Adverse reactions Name fallback brand name: Palonosetron Hydrochloride generic name: PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride PALONOSETRON HYDROCHLORIDE Sagent Pharmaceuticals 6e60d03d-eae6-4924-a507-e77ea077c1ab 2020-04-28 Warnings, Adverse reactions Name fallback brand name: palonosetron hydrochloride generic name: PALONOSETRON HYDROCHLORIDE Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE Teva Parenteral Medicines, Inc. 911783eb-91a8-4ef4-bd6f-809211e207d6 2020-04-01 Warnings, Adverse reactions Name fallback brand name: Palonosetron Hydrochloride generic name: PALONOSETRON HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0143-9513 Palonosetron Hydrochloride Palonosetron Hydrochloride West-Ward Pharmaceuticals Corp NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 46109 ORIG 2016-12-09 46108 ORIG 2016-12-09 45111 ORIG 2016-08-23 45157 ORIG 2016-08-22