Application 205718

Type: NDA
Sponsor: HELSINN HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AKYNZEO	NETUPITANT; PALONOSETRON HYDROCHLORIDE	CAPSULE;ORAL	300MG;EQ 0.5MG BASE	Yes	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205718-001	AKYNZEO	NETUPITANT; PALONOSETRON HYDROCHLORIDE	300MG;EQ 0.5MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-10

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22
N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07
N205718-001	8623826	2030-11-18	U-2293		2014-11-06
N205718-001	8951969	2030-11-18		Drug product	2015-03-06
N205718-001	9186357	2030-11-18	U-2293		2015-12-02
N205718-001	9943515	2030-11-18	U-2293		2018-05-16
N205718-001	10828297	2030-12-17	U-2293		2020-12-04
N205718-001	9271975	2031-09-09	U-2293		2016-07-14
N205718-001	10233154	2035-09-25		Drug substance	2019-03-28
N205718-001	10676440	2035-09-25		Drug substance, Drug product	2020-07-08
N205718-001	10961195	2035-09-25		Drug substance, Drug product	2021-04-15
N205718-001	9951016	2035-09-25		Drug substance, Drug product	2018-05-16

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	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-10	`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	N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	8623826	2030-11-18	U-2293		2014-11-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	8951969	2030-11-18		Drug product	2015-03-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	9186357	2030-11-18	U-2293		2015-12-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	9943515	2030-11-18	U-2293		2018-05-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	10828297	2030-12-17	U-2293		2020-12-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	9271975	2031-09-09	U-2293		2016-07-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	10233154	2035-09-25		Drug substance	2019-03-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	10676440	2035-09-25		Drug substance, Drug product	2020-07-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	10961195	2035-09-25		Drug substance, Drug product	2021-04-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205718-001	9951016	2035-09-25		Drug substance, Drug product	2018-05-16	`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): 205718 application number: NDA205718 ndc (product): 69639-101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67691	SUPPL	2021-06-03
67686	SUPPL	2021-06-03
19676	SUPPL	2015-05-06
19677	SUPPL	2015-05-04
32710	SUPPL	2015-04-29
24502	ORIG	2014-11-07
23000	ORIG	2014-11-07
19675	ORIG	2014-10-14
32709	ORIG	2014-10-10