Application 021656

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRICOR	FENOFIBRATE	TABLET;ORAL	48MG	Yes	No
002	TRICOR	FENOFIBRATE	TABLET;ORAL	145MG	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
N021656-001	TRICOR	FENOFIBRATE	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05
N021656-002	TRICOR	FENOFIBRATE	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05

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UTC	2026-02	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021656-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021656-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021656-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021656-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021656-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021656-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021656-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021656-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021656-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021656-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021656-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021656-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021656-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021656-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021656-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021656-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021656-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021656-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021656-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021656-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021656-002	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	7276249	2023-02-21		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	7320802	2023-02-21	U-847		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	7276249	2023-02-21		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	7320802	2023-02-21	U-847		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	7276249	2023-02-21		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-001	7320802	2023-02-21	U-847		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	7276249	2023-02-21		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	7320802	2023-02-21	U-847		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	7276249	2023-02-21		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-001	7320802	2023-02-21	U-847		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	7276249	2023-02-21		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	7320802	2023-02-21	U-847		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	6375986	2020-09-21	U-615	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-001	7276249	2023-02-21		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-001	7320802	2023-02-21	U-847		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	6375986	2020-09-21	U-615	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	7276249	2023-02-21		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	7320802	2023-02-21	U-847		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	7276249	2023-02-21		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-001	7320802	2023-02-21	U-847		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	7276249	2023-02-21		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	7320802	2023-02-21	U-847		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	7276249	2023-02-21		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-001	7320802	2023-02-21	U-847		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	7276249	2023-02-21		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	7320802	2023-02-21	U-847		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	7276249	2023-02-21		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	7320802	2023-02-21	U-847		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	7276249	2023-02-21		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	7320802	2023-02-21	U-847		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021656-001	7276249	2023-02-21		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-001	7320802	2023-02-21	U-847		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	7276249	2023-02-21		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	7320802	2023-02-21	U-847		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021656-001	6375986	2020-09-21	U-615	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-001	7276249	2023-02-21		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-001	7320802	2023-02-21	U-847		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	6375986	2020-09-21	U-615	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	7276249	2023-02-21		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	7320802	2023-02-21	U-847		`8869cabd3fbd…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tricor	FENOFIBRATE	A-S Medication Solutions	84b2af1b-365e-4723-ac5f-bc826ec47772	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021656 application number: NDA021656 ndc (product): 50090-2899

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3173	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3173	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3173	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3173	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3173	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3189	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3189	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3189	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3189	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0074-3189	Tricor	Fenofibrate	AbbVie Inc.	NDA	Current
0093-7755	Fenofibrate	Fenofibrate	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
0093-7755	Fenofibrate	Fenofibrate	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
0093-7756	Fenofibrate	Fenofibrate	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
0093-7756	Fenofibrate	Fenofibrate	Teva Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
43353-032	Tricor	Fenofibrate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-272	Tricor	Fenofibrate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-2857	Fenofibrate	Fenofibrate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2899	Tricor	Fenofibrate	A-S Medication Solutions	NDA	Current
50090-2899	Tricor	Fenofibrate	A-S Medication Solutions	NDA	Current
51655-010	Fenofibrate	Fenofibrate	Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
51655-902	FENOFIBRATE	FENOFIBRATE	NORTHWIND PHARMACEUTICALS	NDA AUTHORIZED GENERIC	Current
55700-319	Fenofibrate	Fenofibrate	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
63187-940	Fenofibrate	Fenofibrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-940	Fenofibrate	Fenofibrate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63629-6459	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7213	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7213	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7213	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7316	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7316	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68071-2042	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68071-2115	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68151-4717	Fenofibrate	Fenofibrate	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-4718	Fenofibrate	Fenofibrate	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68382-269	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-269	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-269	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-269	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-270	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-270	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-270	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-270	Fenofibrate	Fenofibrate	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82502	SUPPL	2025-06-09
82488	SUPPL	2025-06-09
67756	SUPPL	2021-06-10
67717	SUPPL	2021-06-07
67716	SUPPL	2021-06-07
58190	SUPPL	2019-06-07
58139	SUPPL	2019-03-29
56495	SUPPL	2018-11-16
56386	SUPPL	2018-11-08
54295	SUPPL	2018-05-22
54275	SUPPL	2018-05-21
28322	SUPPL	2013-02-07
15933	SUPPL	2013-02-06
28321	SUPPL	2011-09-26
37408	SUPPL	2011-09-23
15932	SUPPL	2011-09-23
5931	SUPPL	2010-10-25
15931	SUPPL	2010-10-21
5930	SUPPL	2008-04-16
5929	SUPPL	2007-09-25
42255	ORIG	2006-04-21
28320	ORIG	2004-11-08
15930	ORIG	2004-11-08