Application 216457

Type: NDA
Sponsor: HERON THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APONVIE	APREPITANT	EMULSION;INTRAVENOUS	32MG/4.4ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N216457-001	APONVIE	APREPITANT	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS		RLD, RS	2022-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216457-001	10500208	2035-09-18		Drug product	2022-10-05
N216457-001	10624850	2035-09-18	U-3440		2022-10-05
N216457-001	10953018	2035-09-18	U-3440		2022-10-05
N216457-001	11173118	2035-09-18		Drug product	2022-10-05
N216457-001	11744800	2035-09-18	U-3690	Drug product	2023-10-02
N216457-001	11878074	2035-09-18	U-3787		2024-02-06
N216457-001	12115254	2035-09-18		Drug product	2024-11-07
N216457-001	12115255	2035-09-18		Drug product	2024-11-07
N216457-001	12290520	2035-09-18		Drug product	2025-05-12
N216457-001	9561229	2035-09-18	U-3440	Drug product	2022-10-05
N216457-001	9808465	2035-09-18	U-3440		2022-10-05
N216457-001	9974742	2035-09-18		Drug product	2022-10-05
N216457-001	9974793	2035-09-18		Drug product	2022-10-05
N216457-001	9974794	2035-09-18	U-3440	Drug product	2022-10-05

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216457-001	APONVIE	32MG/4.4ML (7.2MG/ML)	EMULSION / INTRAVENOUS	RLD, RS	2022-09-16	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 305 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216457-001	10500208	2035-09-18		Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	10624850	2035-09-18	U-3440		2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	10953018	2035-09-18	U-3440		2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	11173118	2035-09-18		Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	11744800	2035-09-18	U-3690	Drug product	2023-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	11878074	2035-09-18	U-3787		2024-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	12115254	2035-09-18		Drug product	2024-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	12115255	2035-09-18		Drug product	2024-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	12290520	2035-09-18		Drug product	2025-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	9561229	2035-09-18	U-3440	Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	9808465	2035-09-18	U-3440		2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	9974742	2035-09-18		Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	9974793	2035-09-18		Drug product	2022-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216457-001	9974794	2035-09-18	U-3440	Drug product	2022-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216457-001	10500208	2035-09-18		Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	10624850	2035-09-18	U-3440		2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	10953018	2035-09-18	U-3440		2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	11173118	2035-09-18		Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	11744800	2035-09-18	U-3690	Drug product	2023-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	11878074	2035-09-18	U-3787		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	12115254	2035-09-18		Drug product	2024-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	12115255	2035-09-18		Drug product	2024-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	12290520	2035-09-18		Drug product	2025-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	9561229	2035-09-18	U-3440	Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	9808465	2035-09-18	U-3440		2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	9974742	2035-09-18		Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	9974793	2035-09-18		Drug product	2022-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216457-001	9974794	2035-09-18	U-3440	Drug product	2022-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	10500208	2035-09-18		Drug product	2022-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	10624850	2035-09-18	U-3440		2022-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	10953018	2035-09-18	U-3440		2022-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	11173118	2035-09-18		Drug product	2022-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	11744800	2035-09-18	U-3690	Drug product	2023-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	11878074	2035-09-18	U-3787		2024-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	12115254	2035-09-18		Drug product	2024-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	12115255	2035-09-18		Drug product	2024-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	12290520	2035-09-18		Drug product	2025-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	9561229	2035-09-18	U-3440	Drug product	2022-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	9808465	2035-09-18	U-3440		2022-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216457-001	9974742	2035-09-18		Drug product	2022-10-05	`31067a03dcf5…`

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
APONVIE	APREPITANT	Heron Therapeutics, Inc.	d1b111eb-659a-496b-a86a-8f0fa370f147	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216457 application number: NDA216457

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77722	SUPPL	2024-03-05
77718	SUPPL	2024-03-05
74686	ORIG	2023-07-03
72116	ORIG	2022-09-20
72108	ORIG	2022-09-19