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 7 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fenofibrate	FENOFIBRATE	Laurus Labs Limited	0da6d56e-1ed6-437d-b88d-16b014d1889a	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	8e58c13a-8088-4fed-86cc-52530de5aa45	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Proficient Rx LP	b9a6866c-9dbe-4419-bcad-52ec0127821f	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Proficient Rx LP	26f8f793-fb7a-4327-9441-d8737fe1ff11	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	d5c046b5-c3fd-4ef3-8245-c93796d4d880	2022-05-12	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Proficient Rx LP	41f0f514-1fa9-47a0-a085-a31354842f96	2022-03-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	4387adac-eea0-40c5-8111-1b70e0d98d7e	2021-11-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	2985c70d-e85d-483e-8d36-7a4b8454b038	2021-11-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	05957860-eab3-4172-9877-455540d0c922	2021-09-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	fa08cf6a-d306-4979-9b23-ac7febf4fd12	2021-04-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	7e79d495-5d59-485e-b3c2-7c31ba044948	2021-03-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Inc.	9e69d844-5ded-46b6-8321-c420e8b37a63	2021-03-24	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	1e56492f-e2b1-4a07-b697-b59b3a0ac05e	2021-02-24	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	fafbc0be-f0ba-4dcd-8aa5-89527bae5e84	2019-03-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Limited	16ea8ce4-8c1c-4111-509e-86aa688d89a0	2018-12-28	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