Application 022118

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOGLIDE	FENOFIBRATE	TABLET;ORAL	40MG	Yes	No
002	FENOGLIDE	FENOFIBRATE	TABLET;ORAL	120MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N022118-001	FENOGLIDE	FENOFIBRATE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-08-10
N022118-002	FENOGLIDE	FENOFIBRATE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-08-10

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 · 82 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
2026-02-19 14:30 UTC	2026-02	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N022118-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022118-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022118-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022118-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022118-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022118-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022118-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022118-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022118-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022118-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022118-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022118-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022118-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022118-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022118-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022118-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022118-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022118-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022118-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022118-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022118-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022118-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022118-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022118-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022118-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022118-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022118-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022118-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022118-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022118-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022118-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022118-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022118-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022118-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022118-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022118-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022118-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022118-002	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	8481078	2024-10-01	U-1416	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	7658944	2024-12-09		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	8124125	2024-10-01	U-1234	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	8481078	2024-10-01	U-1416	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	7658944	2024-12-09		Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	8481078	2024-10-01	U-1416	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	7658944	2024-12-09		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	8124125	2024-10-01	U-1234	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	8481078	2024-10-01	U-1416	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	7658944	2024-12-09		Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	8481078	2024-10-01	U-1416	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	7658944	2024-12-09		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	8124125	2024-10-01	U-1234	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	8481078	2024-10-01	U-1416	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	7658944	2024-12-09		Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	8481078	2024-10-01	U-1416	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	7658944	2024-12-09		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	8124125	2024-10-01	U-1234	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	8481078	2024-10-01	U-1416	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	7658944	2024-12-09		Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-001	8481078	2024-10-01	U-1416	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-001	7658944	2024-12-09		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	8124125	2024-10-01	U-1234	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	8481078	2024-10-01	U-1416	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	7658944	2024-12-09		Drug product		`d06236e962d9…`

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 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	REMEDYREPACK INC.	b6b5d74d-d418-4ada-8ccd-592b0f57b2ff	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	3b6c5ebd-a8bc-4502-8b66-f4e58914815b	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Major Pharmaceuticals	d9be3ae3-6da9-47fd-bcfd-e561b9d585ca	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	American Health Packaging	8b4488f4-bef6-408c-9fca-3e4aebceff9a	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bostal LLC	7eb328d0-4e6f-4b24-ae85-68c2b3657569	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Sun Pharmaceutical Industries, Inc.	2083f5d9-92f2-4c64-b996-fabbd6946ea0	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Golden State Medical Supply, Inc.	6dd2e25c-aded-4499-e053-2991aa0a9d60	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1ad55-c449-4250-a666-bb36a6ff5b53	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	ce403472-6c0c-4854-bb82-ba6539e1ae07	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals LLC	65f5dcad-5073-4347-9ec9-e7f350b134c4	2026-06-06	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	St. Mary's Medical Park Pharmacy	b92fb19a-d0df-426e-e053-2995a90ab379	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	fa9deae7-6cbf-4559-8130-b86b23b6d0ec	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Rhodes Pharmaceuticals LLC	5e7b79ab-9df0-4bbf-b7a4-a44aec203555	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	b11f1c74-23da-4273-b504-0a2ca22c4b5a	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Westminster Pharmaceuticals, LLC	a97ebf51-4f68-4426-9958-5c59f91b1d47	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Lipofen	FENOFIBRATE	ANI Pharmaceuticals, Inc.	78b789b9-854f-46b9-97f3-a48759a6ff89	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	ANI Pharmaceuticals, Inc.	3a69e15a-eda6-4a6e-8934-6881e4370521	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
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	Golden State Medical Supply, Inc.	3e611f91-e351-9558-e063-6394a90ace17	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1522	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1522	Fenofibrate	Fenofibrate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1522	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1522	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1522	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1522	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1522	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1523	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
52725-490	Fenoglide	fenofibrate	Shore Therapeutics, Inc	NDA	Current
52725-495	Fenoglide	fenofibrate	Shore Therapeutics, Inc	NDA	Current
68012-490	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-490	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-490	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-490	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-490	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-490	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-495	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-495	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-495	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-495	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-495	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68012-495	Fenoglide	fenofibrate	Santarus, Inc.	NDA	Current
68682-490	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA	Current
68682-490	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA	Current
68682-490	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA	Current
68682-490	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA	Current
68682-495	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-495	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-495	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-495	Fenofibrate	fenofibrate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82504	SUPPL	2025-06-09
82490	SUPPL	2025-06-09
67718	SUPPL	2021-06-07
67705	SUPPL	2021-06-04
58760	SUPPL	2019-05-16
58748	SUPPL	2019-05-16
58262	SUPPL	2019-04-09
57995	SUPPL	2019-03-14
54296	SUPPL	2018-05-22
54273	SUPPL	2018-05-21
16986	SUPPL	2012-11-06
6936	SUPPL	2012-11-06
6935	SUPPL	2012-03-14
42422	ORIG	2008-10-30
38284	SUPPL	2008-03-05
6934	SUPPL	2008-03-05
38283	ORIG	2007-08-14
29289	ORIG	2007-08-14