Application 018449

Type: NDA
Sponsor: FRESENIUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTRALIPID 20%	SOYBEAN OIL	INJECTABLE;INJECTION	20%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018449-001	INTRALIPID 20%	SOYBEAN OIL	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018449-001	AP

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018449-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018449-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018449-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018449-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018449-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018449-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018449-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018449-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018449-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018449-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018449-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018449-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018449-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018449-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018449-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018449-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018449-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018449-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018449-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018449-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018449-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018449-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018449-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018449-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018449-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018449-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018449-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018449-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018449-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018449-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018449-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018449-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018449-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018449-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018449-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018449-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018449-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018449-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018449-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018449-001	AP	1	`3a93d1ddd44b…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intralipid	I.V. FAT EMULSION	ProPharma Distribution	48c12fbe-c5e8-a1fc-e063-6294a90a15ae	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449
Intralipid	I.V. FAT EMULSION	Fresenius Kabi USA, LLC	61e025f1-a38e-4af2-9e18-13ea12977cf5	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449
Intralipid	I.V. FAT EMULSION	ProPharma Distribution	42dffe5a-892b-03ec-e063-6394a90ae50c	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	55609586-f0b4-42e6-8dd9-cd090afb5dca	2022-07-21	Boxed warning, Adverse reactions	Exact identifier ndc (product): 0338-0519
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	a69c82da-15ba-4d4d-8d7f-871dc3981eb8	2022-07-21	Boxed warning, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449 ndc (product): 0338-0519
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	cbd3396e-6b85-41bf-82d2-940beba86686	2019-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0338-0519

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0519	Intralipid	I.V. Fat Emulsion	Baxter Healthcare Corporation	NDA	Current
0338-0519	Intralipid	I.V. Fat Emulsion	Baxter Healthcare Corporation	NDA	Current
0338-0519	Intralipid	SOYBEAN OIL	Baxter Healthcare CORP	NDA	Current
0338-0519	Intralipid	SOYBEAN OIL	Baxter Healthcare CORP	NDA	Current
51662-1333	INTRALIPID	INTRALIPID	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1333	INTRALIPID	INTRALIPID	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1333	INTRALIPID	INTRALIPID	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82949	SUPPL	2025-07-28
82925	SUPPL	2025-07-25
74307	SUPPL	2023-05-18
74306	SUPPL	2023-05-18
74283	SUPPL	2023-05-18
74282	SUPPL	2023-05-18
71014	SUPPL	2022-05-06
70988	SUPPL	2022-05-04
55033	SUPPL	2018-07-27
55004	SUPPL	2018-07-26
46060	SUPPL	2016-12-06
46016	SUPPL	2016-12-05
15005	SUPPL	2007-05-01
11220	SUPPL	2007-04-25
15004	SUPPL	2004-04-20