Home Applications 210589 Application 210589
Type NDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMEGAVEN FISH OIL TRIGLYCERIDES EMULSION;INTRAVENOUS 5GM/50ML (0.1GM/ML) Yes Yes 002 OMEGAVEN FISH OIL TRIGLYCERIDES EMULSION;INTRAVENOUS 10GM/100ML (0.1GM/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210589-001 OMEGAVEN FISH OIL TRIGLYCERIDES 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 N210589-002 OMEGAVEN FISH OIL TRIGLYCERIDES 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27
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 · 86 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 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 6 · 232 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 10350186 2024-11-05 U-2585 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 10350186 2024-11-05 U-2585 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 10350186 2024-11-05 U-2585 2019-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 10350186 2024-11-05 U-2585 2019-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 10350186 2024-11-05 U-2585 2019-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 10350186 2024-11-05 U-2585 2019-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 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.
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-205 Omegaven Fish oil Fresenius Kabi USA, LLC NDA Current 63323-205 Omegaven Fish oil Fresenius Kabi USA, LLC NDA Current 63323-205 Omegaven Fish oil Fresenius Kabi USA, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82945 SUPPL 2025-07-28 82930 SUPPL 2025-07-25 74295 SUPPL 2023-05-18 74278 SUPPL 2023-05-18 62932 SUPPL 2020-05-12 62899 SUPPL 2020-05-11 55294 ORIG 2018-08-24 55049 ORIG 2018-07-30 55034 ORIG 2018-07-27