FDA.reportPublic FDA data

Application 207648

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)YesYes
002SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)YesYes
003SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)YesYes
004SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207648-001SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13
N207648-002SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13
N207648-003SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13
N207648-004SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-10

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207648-001SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207648-002SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207648-003SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)EMULSION / INTRAVENOUSRLD, RS2016-07-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207648-004SMOFLIPID 20%3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)EMULSION / INTRAVENOUSRLD, RS2018-08-10d8e5a09893c0…

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-05-13 08:27 UTC2023-05N207648-001NPP2025-03-22053a50430f4f…
2023-05-13 08:27 UTC2023-05N207648-002NPP2025-03-22053a50430f4f…
2023-05-13 08:27 UTC2023-05N207648-003NPP2025-03-22053a50430f4f…
2023-05-13 08:27 UTC2023-05N207648-004NPP2025-03-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N207648-001NPP2025-03-223bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N207648-002NPP2025-03-223bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N207648-003NPP2025-03-223bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N207648-004NPP2025-03-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207648-001NPP2025-03-223a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207648-002NPP2025-03-223a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207648-003NPP2025-03-223a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207648-004NPP2025-03-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N207648-001NPP2025-03-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N207648-002NPP2025-03-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N207648-003NPP2025-03-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N207648-004NPP2025-03-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207648-001NPP2025-03-22e64feba35796…
2022-09-29 23:25 UTC2022-09N207648-002NPP2025-03-22e64feba35796…
2022-09-29 23:25 UTC2022-09N207648-003NPP2025-03-22e64feba35796…
2022-09-29 23:25 UTC2022-09N207648-004NPP2025-03-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207648-001NPP2025-03-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207648-002NPP2025-03-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207648-003NPP2025-03-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207648-004NPP2025-03-22cb3db0bc1861…

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
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 207648
application number: NDA207648
ndc (product): 63323-820

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82946SUPPL 2025-07-28
82929SUPPL 2025-07-25
74296SUPPL 2023-05-18
74277SUPPL 2023-05-18
70586SUPPL2022-03-23
70584SUPPL2022-03-23
62931SUPPL2020-05-12
62898SUPPL2020-05-11
51045ORIG2018-01-12
40591ORIG2016-07-28
10621ORIG2016-07-14