Application 210589

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEGAVENFISH OIL TRIGLYCERIDESEMULSION;INTRAVENOUS5GM/50ML (0.1GM/ML)YesYes
002OMEGAVENFISH OIL TRIGLYCERIDESEMULSION;INTRAVENOUS10GM/100ML (0.1GM/ML)YesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210589-001OMEGAVENFISH OIL TRIGLYCERIDES5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27
N210589-002OMEGAVENFISH OIL TRIGLYCERIDES10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210589-00195662602026-07-30U-2366Drug product2018-08-27
N210589-00295662602026-07-30U-2366Drug product2018-08-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2784e616aacf4f…
2026-09-14 22:38:342026-08N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2784e616aacf4f…
2026-08-18 06:07:402026-07N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210589-001OMEGAVEN5GM/50ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N210589-002OMEGAVEN10GM/100ML (0.1GM/ML)EMULSION / INTRAVENOUSRLD, RS2018-07-2774a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 6 · 232 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N210589-00195662602026-07-30U-2366Drug product2018-08-2784e616aacf4f…
2026-09-14 22:38:342026-08N210589-00295662602026-07-30U-2366Drug product2018-08-2784e616aacf4f…
2026-08-18 06:07:402026-07N210589-00195662602026-07-30U-2366Drug product2018-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07N210589-00295662602026-07-30U-2366Drug product2018-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210589-00195662602026-07-30U-2366Drug product2018-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210589-00295662602026-07-30U-2366Drug product2018-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-00196298212025-07-11U-2367Drug product2018-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-00195662602026-07-30U-2366Drug product2018-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-00296298212025-07-11U-2367Drug product2018-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-00295662602026-07-30U-2366Drug product2018-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210589-00195662602025-07-11U-2366Drug product2018-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210589-00196298212025-07-11U-2367Drug product2018-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210589-00295662602025-07-11U-2366Drug product2018-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210589-00296298212025-07-11U-2367Drug product2018-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-00195662602025-07-11U-2366Drug product2018-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-00196298212025-07-11U-2367Drug product2018-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-00295662602025-07-11U-2366Drug product2018-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-00296298212025-07-11U-2367Drug product2018-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-00195662602025-07-11U-2366Drug product2018-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-00196298212025-07-11U-2367Drug product2018-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-00295662602025-07-11U-2366Drug product2018-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-00296298212025-07-11U-2367Drug product2018-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-001103501862024-11-05U-25852019-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-00195662602025-07-11U-2366Drug product2018-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-00196298212025-07-11U-2367Drug product2018-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-002103501862024-11-05U-25852019-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-00295662602025-07-11U-2366Drug product2018-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-00296298212025-07-11U-2367Drug product2018-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-001103501862024-11-05U-25852019-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-00195662602025-07-11U-2366Drug product2018-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-00196298212025-07-11U-2367Drug product2018-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-002103501862024-11-05U-25852019-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-00295662602025-07-11U-2366Drug product2018-08-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-00296298212025-07-11U-2367Drug product2018-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-001103501862024-11-05U-25852019-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-00195662602025-07-11U-2366Drug product2018-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-00196298212025-07-11U-2367Drug product2018-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-002103501862024-11-05U-25852019-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-00295662602025-07-11U-2366Drug product2018-08-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-00296298212025-07-11U-2367Drug product2018-08-275bbf6a4d5a75…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-001ODE-2022025-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210589-002ODE-2022025-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210589-001ODE-2022025-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210589-002ODE-2022025-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-001ODE-2022025-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210589-002ODE-2022025-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-001ODE-2022025-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210589-002ODE-2022025-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-001ODE-2022025-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210589-002ODE-2022025-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-001ODE-2022025-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210589-002ODE-2022025-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-001ODE-2022025-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210589-002ODE-2022025-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210589-001ODE-2022025-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210589-002ODE-2022025-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210589-001ODE-2022025-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N210589-002ODE-2022025-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210589-001ODE-2022025-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210589-002ODE-2022025-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210589-001ODE-2022025-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210589-002ODE-2022025-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210589-001ODE-2022025-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210589-002ODE-2022025-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210589-001ODE-2022025-07-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N210589-002ODE-2022025-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210589-001NCE2023-07-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210589-001ODE-2022025-07-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210589-002NCE2023-07-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210589-002ODE-2022025-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210589-001NCE2023-07-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210589-001ODE-2022025-07-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210589-002NCE2023-07-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N210589-002ODE-2022025-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210589-001NCE2023-07-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210589-001ODE-2022025-07-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210589-002NCE2023-07-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N210589-002ODE-2022025-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210589-001NCE2023-07-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N210589-001ODE-2022025-07-2774a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmegavenFISH OILFresenius Kabi USA, LLC5d9d0b24-e139-48bf-ab2d-536fb59cf8e02025-09-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 210589
application number: NDA210589
ndc (product): 63323-205

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-205OmegavenFish oilFresenius Kabi USA, LLCNDACurrent
63323-205OmegavenFish oilFresenius Kabi USA, LLCNDACurrent
63323-205OmegavenFish oilFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82945SUPPL 2025-07-28
82930SUPPL 2025-07-25
74295SUPPL 2023-05-18
74278SUPPL 2023-05-18
62932SUPPL2020-05-12
62899SUPPL2020-05-11
55294ORIG2018-08-24
55049ORIG2018-07-30
55034ORIG2018-07-27