Application 204508

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINOLIPID 20%	OLIVE OIL; SOYBEAN OIL	EMULSION;INTRAVENOUS	16%(160GM/1000ML);4% (40GM/1000ML)	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
N204508-001	CLINOLIPID 20%	OLIVE OIL; SOYBEAN OIL	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS		RLD, RS	2013-10-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204508-001	NPP	2027-04-24

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD	2013-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204508-001	CLINOLIPID 20%	16%(160GM/1000ML);4% (40GM/1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2013-10-03	`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N204508-001	NPP	2027-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204508-001	NPP	2027-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204508-001	NPP	2027-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204508-001	NPP	2027-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204508-001	NPP	2027-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204508-001	NPP	2027-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204508-001	NPP	2027-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204508-001	NPP	2027-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204508-001	NPP	2027-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204508-001	NPP	2027-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204508-001	NPP	2027-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204508-001	NPP	2027-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204508-001	NPP	2027-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204508-001	NPP	2027-04-24	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204508-001	NPP	2027-04-24	`a50c72e98297…`

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
Clinolipid	OLIVE OIL AND SOYBEAN OIL	Baxter Healthcare Corporation	ae98eb03-c0e7-49d1-b024-77968e3d9d6e	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204508 application number: NDA204508 ndc (product): 0338-9540

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
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current
0338-9540	Clinolipid	Olive Oil and Soybean Oil	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82957	SUPPL	2025-07-28
82956	SUPPL	2025-07-28
82940	SUPPL	2025-07-25
78261	SUPPL	2024-04-25
78242	SUPPL	2024-04-25
74301	SUPPL	2023-05-18
74300	SUPPL	2023-05-18
74294	SUPPL	2023-05-18
74293	SUPPL	2023-05-18
67074	SUPPL	2021-04-16
67059	SUPPL	2021-04-14
10349	SUPPL	2016-07-22
40395	SUPPL	2016-07-21
44903	ORIG	2014-10-07
43466	ORIG	2014-10-07
19568	ORIG	2013-10-08
32565	ORIG	2013-10-04