Application 204078

Type: NDA
Sponsor: AVADEL LEGACY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	5MG/10ML (0.5MG/ML)	Yes	Yes
002	BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	10MG/10ML (1MG/ML)	Yes	Yes
003	BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	SOLUTION;INTRAVENOUS	5MG/5ML (1MG/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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204078-001	BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-05-31
N204078-002	BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2013-05-31
N204078-003	BLOXIVERZ	NEOSTIGMINE METHYLSULFATE	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2023-10-27

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 · 106 observed 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
2026-09-14 22:38:34	2026-08	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2013-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204078-002	BLOXIVERZ	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204078-003	BLOXIVERZ	5MG/5ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204078-001	BLOXIVERZ	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-05-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204078-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204078-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204078-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204078-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204078-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204078-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204078-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204078-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204078-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204078-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204078-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204078-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204078-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204078-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204078-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204078-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204078-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204078-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204078-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204078-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204078-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204078-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204078-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204078-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204078-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204078-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204078-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204078-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204078-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204078-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204078-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204078-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204078-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204078-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204078-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204078-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204078-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204078-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204078-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204078-002	AP	1	`87673890dc5c…`

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
Bloxiverz	NEOSTIGMINE METHYLSULFATE	Exela Pharma Sciences, LLC	d2f55643-2b0d-4ef9-a9d8-b7138b314372	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204078 application number: NDA204078 ndc (product): 51754-1220 ndc (product): 51754-1210

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-1210	Bloxiverz	Neostigmine Methylsulfate	Exela Pharma Sciences, LLC	NDA	Current
51754-1210	Bloxiverz	Neostigmine Methylsulfate	Exela Pharma Sciences, LLC	NDA	Current
51754-1220	Bloxiverz	Neostigmine Methylsulfate	Exela Pharma Sciences, LLC	NDA	Current
51754-1220	Bloxiverz	Neostigmine Methylsulfate	Exela Pharma Sciences, LLC	NDA	Current
51754-1240	Bloxiverz	neostigmine methylsulfate	Exela Pharma Sciences, LLC	NDA	Current
51754-1240	Bloxiverz	neostigmine methylsulfate	Exela Pharma Sciences, LLC	NDA	Current
68001-329	Bloxiverz	Neostigmine Methylsulfate	BluePoint Laboratories	NDA	Current
76014-002	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-002	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-003	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-003	Bloxiverz	Neostigmine Methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-902	Bloxiverz	neostigmine methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-903	Bloxiverz	neostigmine methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-903	Bloxiverz	neostigmine methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current
76014-903	Bloxiverz	neostigmine methylsulfate	Avadel Legacy Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76871	SUPPL	2023-12-15
76856	SUPPL	2023-12-15
65955	SUPPL	2021-01-22
65947	SUPPL	2021-01-21
19524	SUPPL	2015-10-22
32503	SUPPL	2015-10-21
40352	SUPPL	2014-12-16
10293	SUPPL	2014-12-12
44894	ORIG	2014-05-27
43455	ORIG	2014-05-27
32502	ORIG	2013-06-04
19523	ORIG	2013-06-04
51400	ORIG	1900-01-01
51399	ORIG	1900-01-01