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 43.

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2018-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	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	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	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	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	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	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210493-001	AKYNZEO	EQ 235MG BASE;EQ 0.25MG BASE	POWDER / INTRAVENOUS	RLD, RS	2018-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210493-001	AKYNZEO	EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-04-19	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 850 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210493-001	9186357	2030-11-18	U-2301		2018-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	10828297	2030-12-17	U-2301		2020-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	10208073	2032-05-23	U-2301		2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	10717721	2032-05-23		Drug substance	2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	8426450	2032-05-23		Drug substance, Drug product	2018-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	8895586	2032-05-23	U-2301		2018-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	9403772	2032-05-23	U-2301	Drug substance	2018-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	9908907	2032-05-23		Drug substance, Drug product	2018-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	10624911	2037-06-02		Drug product	2020-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	11529362	2037-06-02		Drug product	2023-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-001	12208109	2037-06-02		Drug product	2025-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	9186357	2030-11-18	U-2301		2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	10828297	2030-12-17	U-2301		2020-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	10208073	2032-05-23	U-2301		2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	10717721	2032-05-23		Drug substance	2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	8426450	2032-05-23		Drug substance, Drug product	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	8895586	2032-05-23	U-2301		2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	9403772	2032-05-23	U-2301	Drug substance	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	9908907	2032-05-23		Drug substance, Drug product	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	10624911	2037-06-02		Drug product	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	11529362	2037-06-02		Drug product	2023-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210493-002	12208109	2037-06-02		Drug product	2025-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210493-001	9186357	2030-11-18	U-2301		2018-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	10828297	2030-12-17	U-2301		2020-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	10208073	2032-05-23	U-2301		2019-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	10717721	2032-05-23		Drug substance	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	11312698	2032-05-23		Drug substance, Drug product	2022-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	8426450	2032-05-23		Drug substance, Drug product	2018-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	8895586	2032-05-23	U-2301		2018-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	9403772	2032-05-23	U-2301	Drug substance	2018-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	9908907	2032-05-23		Drug substance, Drug product	2018-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	10624911	2037-06-02		Drug product	2020-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	11529362	2037-06-02		Drug product	2023-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-001	12208109	2037-06-02		Drug product	2025-02-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-002	9186357	2030-11-18	U-2301		2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-002	10828297	2030-12-17	U-2301		2020-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-002	10208073	2032-05-23	U-2301		2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210493-002	10717721	2032-05-23		Drug substance	2020-08-19	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210493-001	NCE	2023-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210493-002	NCE	2023-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210493-001	NCE	2023-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210493-002	NCE	2023-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210493-001	NCE	2023-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210493-002	NCE	2023-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210493-001	NCE	2023-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210493-001	NCE	2023-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210493-002	NCE	2023-04-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210493-001	NCE	2023-04-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210493-002	NCE	2023-04-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210493-001	NCE	2023-04-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210493-002	NCE	2023-04-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210493-001	NCE	2023-04-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210493-002	NCE	2023-04-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210493-001	NCE	2023-04-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210493-002	NCE	2023-04-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210493-001	NCE	2023-04-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210493-002	NCE	2023-04-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210493-001	NCE	2023-04-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210493-001	NCE	2023-04-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210493-001	NCE	2023-04-19	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N210493-001	NCE	2023-04-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N210493-002	NCE	2023-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210493-001	NCE	2023-04-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210493-002	NCE	2023-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210493-001	NCE	2023-04-19	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210493-002	NCE	2023-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210493-001	NCE	2023-04-19	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210493-002	NCE	2023-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210493-001	NCE	2023-04-19	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210493-002	NCE	2023-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210493-001	NCE	2023-04-19	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N210493-002	NCE	2023-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210493-001	NCE	2023-04-19	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N210493-002	NCE	2023-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210493-001	NCE	2023-04-19	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210493-002	NCE	2023-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210493-001	NCE	2023-04-19	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N210493-002	NCE	2023-04-19	`f41ea6bd6efb…`

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
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

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 · 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