Application 021203

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRICOR	FENOFIBRATE	TABLET;ORAL	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	TRICOR	FENOFIBRATE	TABLET;ORAL	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021203-001	TRICOR	FENOFIBRATE	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-09-04
N021203-003	TRICOR	FENOFIBRATE	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-09-04

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021203-001	TRICOR	54MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021203-003	TRICOR	160MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-09-04	`3a93d1ddd44b…`

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 · 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	c870ea48-5dde-4a6f-9ddb-56b494bb2b55	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	882ee82a-3c56-4173-af42-68c3aadc8aa7	2026-09-04	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d0c7070e-b3bb-4b5b-8a62-4e3136b5accc	2026-08-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
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	Golden State Medical Supply, Inc.	3e611f91-e351-9558-e063-6394a90ace17	2026-07-27	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
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58189	SUPPL	2019-06-07
58138	SUPPL	2019-03-29
56494	SUPPL	2018-11-16
56387	SUPPL	2018-11-08
54294	SUPPL	2018-05-22
54274	SUPPL	2018-05-21
47008	SUPPL	2017-01-30
46975	SUPPL	2017-01-25
14629	SUPPL	2014-12-10
27053	SUPPL	2014-12-09
42019	ORIG	2005-04-15
36337	ORIG	2001-09-05
27052	ORIG	2001-09-05