Application 022325

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEXTERONE	AMIODARONE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	NEXTERONE	AMIODARONE HYDROCHLORIDE	INJECTABLE;INJECTION	150MG/100ML (1.5MG/ML)	Yes	Yes
003	NEXTERONE	AMIODARONE HYDROCHLORIDE	INJECTABLE;INJECTION	360MG/200ML (1.8MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022325-001	NEXTERONE	AMIODARONE HYDROCHLORIDE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24
N022325-002	NEXTERONE	AMIODARONE HYDROCHLORIDE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16
N022325-003	NEXTERONE	AMIODARONE HYDROCHLORIDE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022325-001	7635773	2029-03-13	Drug product
N022325-002	10117951	2029-03-13	Drug product	2026-06-03
N022325-002	7635773	2029-03-13	Drug product
N022325-002	8410077	2029-03-13	Drug product	2026-04-21
N022325-002	9200088	2029-03-13	Drug product	2026-04-21
N022325-002	9750822	2029-03-13	Drug product	2026-04-21
N022325-002	9493582	2033-02-27	Drug product	2026-04-21
N022325-003	10117951	2029-03-13	Drug product	2026-06-03
N022325-003	7635773	2029-03-13	Drug product
N022325-003	8410077	2029-03-13	Drug product	2026-04-21
N022325-003	9200088	2029-03-13	Drug product	2026-04-21
N022325-003	9750822	2029-03-13	Drug product	2026-04-21
N022325-003	9493582	2033-02-27	Drug product	2026-04-21

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022325-002	NEXTERONE	150MG/100ML (1.5MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022325-003	NEXTERONE	360MG/200ML (1.8MG/ML)	INJECTABLE / INJECTION	RLD, RS	2010-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022325-001	NEXTERONE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2008-12-24	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022325-001	7635773	2029-03-13	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	10117951	2029-03-13	Drug product	2026-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	7635773	2029-03-13	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	8410077	2029-03-13	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	9200088	2029-03-13	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	9750822	2029-03-13	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-002	9493582	2033-02-27	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	10117951	2029-03-13	Drug product	2026-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	7635773	2029-03-13	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	8410077	2029-03-13	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	9200088	2029-03-13	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	9750822	2029-03-13	Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022325-003	9493582	2033-02-27	Drug product	2026-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022325-001	7635773	2029-03-13	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022325-002	7635773	2029-03-13	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022325-003	7635773	2029-03-13	Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022325-001	7635773	2029-03-13	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022325-002	7635773	2029-03-13	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022325-003	7635773	2029-03-13	Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022325-001	7635773	2029-03-13	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022325-002	7635773	2029-03-13	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022325-003	7635773	2029-03-13	Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022325-001	7635773	2029-03-13	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022325-002	7635773	2029-03-13	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022325-003	7635773	2029-03-13	Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022325-001	7635773	2029-03-13	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022325-002	7635773	2029-03-13	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022325-003	7635773	2029-03-13	Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022325-001	7635773	2029-03-13	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022325-002	7635773	2029-03-13	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022325-003	7635773	2029-03-13	Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022325-001	7635773	2029-03-13	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022325-002	7635773	2029-03-13	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022325-003	7635773	2029-03-13	Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022325-001	7635773	2029-03-13	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022325-002	7635773	2029-03-13	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022325-003	7635773	2029-03-13	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022325-001	7635773	2029-03-13	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022325-002	7635773	2029-03-13	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022325-003	7635773	2029-03-13	Drug product		`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexterone	AMIODARONE HYDROCHLORIDE	Baxter Healthcare Corporation	e9108958-b8d7-4fba-87c3-9a32990de551	2024-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022325 application number: NDA022325 ndc (product): 43066-150 ndc (product): 43066-360
NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)	HF Acquisition Co LLC, DBA HealthFirst	9d4d66f7-fa14-e832-e053-2a95a90a8b62	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022325 application number: NDA022325 ndc (product): 51662-1480 ndc (product): 51662-1481

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43066-150	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-150	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-150	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-150	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-150	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-150	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-360	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-360	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-360	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-360	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-360	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
43066-360	Nexterone	amiodarone hydrochloride	Baxter Healthcare Corporation	NDA	Current
51662-1480	NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1480	NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1481	NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1481	NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81364	SUPPL	2025-02-25
81355	SUPPL	2025-02-25
68574	SUPPL	2021-09-10
68562	SUPPL	2021-09-08
50610	SUPPL	2017-12-06
47703	SUPPL	2017-03-24
47678	SUPPL	2017-03-24
46001	SUPPL	2016-12-02
45954	SUPPL	2016-11-23
38576	SUPPL	2015-03-17
29596	SUPPL	2015-03-17
29595	SUPPL	2011-12-14
38575	SUPPL	2011-12-12
7237	SUPPL	2010-11-22
17242	SUPPL	2010-11-18
24283	ORIG	2010-02-17
21993	ORIG	2010-02-17
38574	ORIG	2009-01-02
7236	ORIG	2009-01-02