Application 021350

Type: NDA
Sponsor: SKYEPHARMA AG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIGLIDE	FENOFIBRATE	TABLET;ORAL	50MG	No	No
002	TRIGLIDE	FENOFIBRATE	TABLET;ORAL	160MG	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021350-001	TRIGLIDE	FENOFIBRATE	50MG	TABLET / ORAL			2005-05-07
N021350-002	TRIGLIDE	FENOFIBRATE	160MG	TABLET / ORAL		RLD	2005-05-07

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021350-002	TRIGLIDE	160MG	TABLET / ORAL		RLD	2005-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021350-001	TRIGLIDE	50MG	TABLET / ORAL			2005-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021350-002	TRIGLIDE	160MG	TABLET / ORAL	BX	RLD	2005-05-07	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021350-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021350-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021350-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021350-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021350-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021350-002	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021350-002	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021350-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021350-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021350-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021350-002	BX	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021350-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021350-002	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021350-002	BX	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021350-002	BX	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021350-002	BX	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021350-002	BX	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021350-002	BX	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021350-002	BX	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021350-002	BX	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021350-002	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021350-002	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021350-002	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021350-002	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021350-002	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021350-002	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021350-002	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021350-002	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021350-002	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021350-002	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021350-002	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021350-002	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021350-002	BX	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021350-001	6696084	2021-09-11	U-680	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021350-002	6696084	2021-09-11	U-680	Drug substance, Drug product	`ea99ee380514…`

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 2 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	df9f67d6-3cd9-4f44-8020-2d6ef53c30b5	2026-05-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bostal LLC	a5bc232c-ff27-f8b6-e053-2995a90ad399	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals, Inc.	c810b16b-32e2-4d0c-aa28-bf1f62110757	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	e573b3f1-5a4c-4a19-9f0f-ee797b379a08	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Safecor Health, LLC	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	3389b846-8926-3ad5-e063-6294a90aee39	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f443dd79-46da-4b02-8188-7417d39cf975	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Macleods Pharmaceuticals Limited	a504c42a-b629-4a21-a716-084962266b48	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	2f5cee5c-ec55-4e9b-9d54-e7f2f052130e	2026-02-26	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	bdc2211e-6d65-1500-e053-2a95a90ab145	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	bbeae8e4-e06a-4c19-a1b9-f6143306dab9	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	b79efcf4-6016-4a1f-b83f-be00baa25c21	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bostal LLC	edace25a-3296-9ca7-dcb8-d0698f65840d	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d9c60b43-dc61-4976-b31f-09c8f8a33138	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Glenmark Pharmaceuticals Inc., USA	e7204052-02cf-4b38-835b-d8754c74b2cd	2026-01-31	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvKARE	f669f231-98b9-5014-e053-2a95a90a4e4c	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvKARE	0e240290-f11b-8cc4-e063-6294a90a74f0	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	A-S Medication Solutions	58f0d475-24dc-4f93-aa40-3882b724b70f	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Major Pharmaceuticals	bbffd586-f63a-4a84-bdfb-3e4a1df6449e	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvPAK	e949c068-bc7d-3038-e053-2a95a90aee00	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59630-485	TRIGLIDE	FENOFIBRATE	Shionogi Inc.	NDA	Current
69597-346	FENOFIBRATE	FENOFIBRATE	Basiem	NDA	Current
70199-013	TRIGLIDE	FENOFIBRATE	Casper Pharma LLC	NDA	Current
70199-013	TRIGLIDE	FENOFIBRATE	Casper Pharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78507	SUPPL	2024-05-20
78477	SUPPL	2024-05-15
67746	SUPPL	2021-06-08
67721	SUPPL	2021-06-07
58761	SUPPL	2019-05-16
54297	SUPPL	2018-05-22
54272	SUPPL	2018-05-21
5128	SUPPL	2015-11-16
27563	SUPPL	2015-04-17
36730	SUPPL	2015-04-16
36729	SUPPL	2013-01-22
5127	SUPPL	2013-01-17
5126	SUPPL	2012-04-23
36728	SUPPL	2012-04-20
15256	SUPPL	2008-11-19
27562	SUPPL	2008-11-18
15255	SUPPL	2008-01-18
5125	SUPPL	2008-01-18
42115	ORIG	2007-09-10
27561	SUPPL	2006-07-13
36727	SUPPL	2006-07-05
15254	ORIG	2005-05-17
5124	ORIG	2005-05-17