Application 210493

Type: NDA
Sponsor: HELSINN HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	POWDER;INTRAVENOUS	EQ 235MG BASE;EQ 0.25MG BASE	Yes	Yes
002	AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	Yes	Yes

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

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
N210493-001	AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2018-04-19
N210493-002	AKYNZEO	FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE	EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210493-001	9186357	2030-11-18	U-2301		2018-05-17
N210493-001	10828297	2030-12-17	U-2301		2020-12-09
N210493-001	10208073	2032-05-23	U-2301		2019-03-08
N210493-001	10717721	2032-05-23		Drug substance	2020-08-19
N210493-001	11312698	2032-05-23		Drug substance, Drug product	2022-05-13
N210493-001	8426450	2032-05-23		Drug substance, Drug product	2018-05-17
N210493-001	8895586	2032-05-23	U-2301		2018-05-17
N210493-001	9403772	2032-05-23	U-2301	Drug substance	2018-05-17
N210493-001	9908907	2032-05-23		Drug substance, Drug product	2018-05-17
N210493-001	10624911	2037-06-02		Drug product	2020-05-26
N210493-001	11529362	2037-06-02		Drug product	2023-01-17
N210493-001	12208109	2037-06-02		Drug product	2025-02-20
N210493-002	9186357	2030-11-18	U-2301		2020-06-24
N210493-002	10828297	2030-12-17	U-2301		2020-12-09
N210493-002	10208073	2032-05-23	U-2301		2020-06-24
N210493-002	10717721	2032-05-23		Drug substance	2020-08-19
N210493-002	11312698	2032-05-23		Drug substance, Drug product	2022-05-13
N210493-002	8426450	2032-05-23		Drug substance, Drug product	2020-06-24
N210493-002	8895586	2032-05-23	U-2301		2020-06-24
N210493-002	9403772	2032-05-23	U-2301	Drug substance	2020-06-24
N210493-002	9908907	2032-05-23		Drug substance, Drug product	2020-06-24
N210493-002	10624911	2037-06-02		Drug product	2020-06-24
N210493-002	11529362	2037-06-02		Drug product	2023-01-17
N210493-002	12208109	2037-06-02		Drug product	2025-02-20

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2018-04-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	AKYNZEO	EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-05-27	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N210493-001	9186357	2030-11-18	U-2301		2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10828297	2030-12-17	U-2301		2020-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10208073	2032-05-23	U-2301		2019-03-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10717721	2032-05-23		Drug substance	2020-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	8426450	2032-05-23		Drug substance, Drug product	2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	8895586	2032-05-23	U-2301		2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	9403772	2032-05-23	U-2301	Drug substance	2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	9908907	2032-05-23		Drug substance, Drug product	2018-05-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	10624911	2037-06-02		Drug product	2020-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	11529362	2037-06-02		Drug product	2023-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-001	12208109	2037-06-02		Drug product	2025-02-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	9186357	2030-11-18	U-2301		2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10828297	2030-12-17	U-2301		2020-12-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10208073	2032-05-23	U-2301		2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10717721	2032-05-23		Drug substance	2020-08-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	8426450	2032-05-23		Drug substance, Drug product	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	8895586	2032-05-23	U-2301		2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	9403772	2032-05-23	U-2301	Drug substance	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	9908907	2032-05-23		Drug substance, Drug product	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	10624911	2037-06-02		Drug product	2020-06-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	11529362	2037-06-02		Drug product	2023-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N210493-002	12208109	2037-06-02		Drug product	2025-02-20	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AKYNZEO	NETUPITANT AND PALONOSETRON	Helsinn Therapeutics (U.S.), Inc.	8e47618e-af46-4d82-94e8-1507c042252d	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210493 application number: NDA210493 ndc (product): 69639-102 ndc (product): 69639-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69639-102	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-102	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-102	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-102	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-102	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-102	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-105	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-105	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-105	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-105	AKYNZEO	Fosnetupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73532	SUPPL	2023-04-14
73524	SUPPL	2023-02-16
67696	SUPPL	2021-06-03
67685	SUPPL	2021-06-03
65106	SUPPL	2020-10-30
65084	SUPPL	2020-10-30
64206	SUPPL	2020-08-05
64205	SUPPL	2020-08-05
54390	ORIG	2018-05-31
53774	ORIG	2018-04-23
53747	ORIG	2018-04-20