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 4 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Ajanta Pharma USA Inc.	da2f0ba4-7c16-4fb0-bc1c-45540e8fefbf	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	American Health Packaging	d1f64796-6ba0-415c-a6a0-5456b21a7ed6	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	24790a18-0291-4b88-a724-acac43b616ce	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	ba8e809e-f6b5-4ba8-9108-81cc82b14225	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	8eee54d1-48ca-4704-93f3-0ac6fd7f464e	2025-09-18	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	40ca5d88-6403-4c4b-ae7f-ae8cec4d9965	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	QUALLENT PHARMACEUTICALS HEALTH LLC	215a5000-9f89-47d9-b2d5-94e13f5e1767	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	5b67f389-55e8-466b-82bd-5ea992f630aa	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	NorthStar RxLLC	3b448774-aebf-45fe-92f1-b8eca53cf09b	2025-09-13	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	0f958942-1504-40a1-8ad8-43df2c3f717e	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Trifluent Pharma LLC	3c3539e4-bc4a-8152-e063-6294a90ab55c	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals Inc.	2e6711e9-782d-46bd-9447-6612fe7d0fe7	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	84fcea7a-05ed-44c2-98fa-7e87b28d2261	2025-07-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	ANI Pharmaceuticals, Inc.	c740f57c-cac5-4526-a5a9-aaab65b1caf6	2025-07-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Mylan Institutional Inc.	5a90e0a4-7892-462f-9776-037d23a93b10	2025-07-25	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Camber Pharmaceuticals, Inc.	38f43148-4ca0-402a-ba39-8ee5011a7907	2025-07-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Alembic Pharmaceuticals Inc.	5c579378-e00e-4802-b9d3-c062cf8bd9f4	2025-07-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Macleods Pharmaceuticals Limited	e8b9d1f5-0541-424f-b1d4-bef6381aa934	2025-07-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	283e754e-6ffa-4d6a-882f-9bbb3cbc8ca8	2025-06-25	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	556c4800-24f6-4237-8636-3211997cbb03	2025-06-10	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