Home Applications 208289 Application 208289
Type NDA
Sponsor AVADEL LEGACY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AKOVAZ EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) Yes Yes 002 AKOVAZ EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 25MG/5ML (5MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N208289-001 AKOVAZ EPHEDRINE SULFATE 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 N208289-002 AKOVAZ EPHEDRINE SULFATE 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 74 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 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP3 RLD, RS 2021-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2021-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208289-002 AKOVAZ 25MG/5ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208289-001 AKOVAZ 50MG/ML (50MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-29 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51754-4200 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 51754-4200 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 51754-4200 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 51754-4200 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 51754-4250 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 51754-4250 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 51754-4250 Akovaz ephedrine sulfate Exela Pharma Sciences, LLC NDA Current 68001-330 Akovaz ephedrine sulfate BluePoint Laboratories NDA Current 68001-330 Akovaz ephedrine sulfate BluePoint Laboratories NDA Current 76014-005 Akovaz ephedrine sulfate Avadel Legacy Pharmaceuticals, LLC NDA Current 76014-005 Akovaz ephedrine sulfate Avadel Legacy Pharmaceuticals, LLC NDA Current 76014-005 Akovaz ephedrine sulfate Avadel Legacy Pharmaceuticals, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71466 SUPPL 2022-06-28 68624 SUPPL 2021-09-15 68293 SUPPL 2021-08-04 62537 SUPPL 2020-04-10 62523 SUPPL 2020-04-09 55227 SUPPL 2018-08-20 55166 SUPPL 2018-08-13 44974 ORIG 2016-05-24 23054 ORIG 2016-05-24 19990 ORIG 2016-05-05 10653 ORIG 2016-05-04