Home Applications 204078 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 1 .
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 TE codes 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 · 100 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 2026-02-19 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204078-002 BLOXIVERZ 10MG/10ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204078-003 BLOXIVERZ 5MG/5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2023-10-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204078-001 BLOXIVERZ 5MG/10ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2013-05-31 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
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.
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