Application 017643

Type: NDA
Sponsor: FRESENIUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTRALIPID 10%	SOYBEAN OIL	INJECTABLE;INJECTION	10%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N017643-001	INTRALIPID 10%	SOYBEAN OIL	10%	INJECTABLE / INJECTION		RLD, Approved before 1982

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 · 43 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
2022-09-29 23:25 UTC	2022-09	N017643-001	INTRALIPID 10%	10%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017643-001	INTRALIPID 10%	10%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017643-001	INTRALIPID 10%	10%	INJECTABLE / INJECTION		RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017643-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017643-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017643-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017643-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017643-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017643-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017643-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017643-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017643-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017643-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017643-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017643-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017643-001	AP	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017643-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017643-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017643-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017643-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017643-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017643-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017643-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017643-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017643-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017643-001	AP	1	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intralipid	I.V. FAT EMULSION	Baxter Healthcare CORP	069460a5-3e9a-428f-b2dc-3405690f4fd7	2022-07-25	Boxed warning, Adverse reactions	Exact identifier application applno (NDA): 017643 application number: NDA017643 ndc (product): 0338-0518

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
0338-0518	Intralipid	I.V. Fat Emulsion	Baxter Healthcare CORP	NDA	Current
0338-0518	Intralipid	I.V. Fat Emulsion	Baxter Healthcare CORP	NDA	Current
0338-0518	Intralipid	SOYBEAN OIL	Baxter Healthcare CORP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82948	SUPPL	2025-07-28
82985	SUPPL	2025-07-25
74305	SUPPL	2023-05-18
74281	SUPPL	2023-05-18
71015	SUPPL	2022-05-06
70987	SUPPL	2022-05-04
55032	SUPPL	2018-07-27
55003	SUPPL	2018-07-26
46059	SUPPL	2016-12-06
46015	SUPPL	2016-12-05
671	SUPPL	2007-05-01
33324	SUPPL	2007-04-25
670	SUPPL	2004-04-20