Application 021372

Type: NDA
Sponsor: HELSINN HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALOXI	PALONOSETRON HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	Yes	Yes
002	ALOXI	PALONOSETRON HYDROCHLORIDE	INJECTABLE;INTRAVENOUS	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021372-001	ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25
N021372-002	ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-07-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2008-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-07-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2008-02-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	RLD	2003-07-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	RLD	2008-02-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2003-07-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2008-02-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021372-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021372-002	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021372-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021372-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021372-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021372-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021372-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021372-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021372-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021372-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021372-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021372-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021372-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021372-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021372-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021372-002	AP	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 37 · 1,470 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947724	2024-01-30		Drug product	2011-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947725	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7960424	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8518981	2024-01-30		Drug product	2013-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598218	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598219	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8729094	2024-01-30	U-528	Drug product	2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9066980	2024-01-30	U-528	Drug product	2015-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9125905	2024-01-30		Drug product	2015-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9173942	2024-01-30		Drug product	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9439854	2024-01-30		Drug product	2016-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457020	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457021	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947724*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947725*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7960424*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8518981*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598218*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598219*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8729094*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9066980*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9125905*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9173942*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9439854*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457020*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457021*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947724	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947725	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7960424	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8518981	2024-01-30		Drug product	2013-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8598218	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9173942	2024-01-30		Drug product	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9439854	2024-01-30		Drug product	2016-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9457020	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947724*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947725*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7960424*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8518981*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8598218*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9173942*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
palonosetron hydrochloride	PALONOSETRON HYDROCHLORIDE	Cipla USA Inc.	37e7ef89-fd77-44e0-9271-ae91f8822603	2022-01-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021372 application number: NDA021372 ndc (product): 69097-927

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-365	palonosetron hydrochloride	palonosetron hydrochloride	Accord Healthcare, Inc.	NDA AUTHORIZED GENERIC	Current
16729-365	palonosetron hydrochloride	palonosetron hydrochloride	Accord Healthcare, Inc.	NDA AUTHORIZED GENERIC	Current
16729-365	palonosetron hydrochloride	palonosetron hydrochloride	Accord Healthcare, Inc.	NDA AUTHORIZED GENERIC	Current
62856-797	Aloxi	palonosetron hydrochloride	Eisai Inc.	NDA	Current
62856-797	Aloxi	palonosetron hydrochloride	Eisai Inc.	NDA	Current
62856-798	Aloxi	palonosetron hydrochloride	Eisai Inc.	NDA	Current
62856-798	Aloxi	palonosetron hydrochloride	Eisai Inc.	NDA	Current
69097-927	palonosetron hydrochloride	palonosetron hydrochloride	Cipla USA Inc.	NDA AUTHORIZED GENERIC	Current
69097-927	palonosetron hydrochloride	palonosetron hydrochloride	Cipla USA Inc.	NDA AUTHORIZED GENERIC	Current
69097-927	palonosetron hydrochloride	palonosetron hydrochloride	Cipla USA Inc.	NDA AUTHORIZED GENERIC	Current
69639-103	Aloxi	palonosetron hydrochloride	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-103	Aloxi	palonosetron hydrochloride	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-103	Aloxi	palonosetron hydrochloride	Helsinn Therapeutics (U.S.), Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62422	SUPPL	2020-04-02
62419	SUPPL	2020-04-02
5218	SUPPL	2014-09-23
15338	SUPPL	2014-09-22
27629	SUPPL	2014-06-02
5217	SUPPL	2014-06-02
15337	SUPPL	2014-05-28
27628	SUPPL	2014-02-11
36794	SUPPL	2014-02-07
44641	SUPPL	2009-12-12
42126	SUPPL	2009-12-12
24195	SUPPL	2009-12-12
21627	SUPPL	2009-12-12
36793	SUPPL	2008-03-05
15336	SUPPL	2008-03-05
5216	SUPPL	2008-03-05
5215	SUPPL	2008-03-05
27627	SUPPL	2007-09-04
15335	SUPPL	2007-09-04
5214	SUPPL	2006-09-18
36792	SUPPL	2006-08-29
5213	SUPPL	2005-07-08
15334	SUPPL	2005-07-07
21626	ORIG	2004-01-15
36791	ORIG	2003-08-06
27626	ORIG	2003-08-06
64037	ORIG	1900-01-01
64036	ORIG	1900-01-01
64035	ORIG	1900-01-01
64034	ORIG	1900-01-01
58110	SUPPL	1900-01-01
51540	SUPPL	1900-01-01
51539	SUPPL	1900-01-01
51538	SUPPL	1900-01-01
51537	SUPPL	1900-01-01