Application 022418

Type: NDA
Sponsor: ATHENA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FIBRICOR	FENOFIBRIC ACID	TABLET;ORAL	35MG	Yes	No
002	FIBRICOR	FENOFIBRIC ACID	TABLET;ORAL	105MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022418-001	FIBRICOR	FENOFIBRIC ACID	35MG	TABLET / ORAL		RLD	2009-08-14
N022418-002	FIBRICOR	FENOFIBRIC ACID	105MG	TABLET / ORAL		RLD	2009-08-14

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022418-001	7569612	2027-08-20	U-1000
N022418-001	7741373	2027-08-20	U-1059
N022418-001	7741374	2027-08-20	U-1060
N022418-001	7741374	2027-08-20	U-1061
N022418-001	7915247	2027-08-20	U-1000	2011-03-30
N022418-001	7915247	2027-08-20	U-1059	2011-03-30
N022418-001	7915247	2027-08-20	U-1061	2011-03-30
N022418-002	7569612	2027-08-20	U-1000
N022418-002	7741373	2027-08-20	U-1059
N022418-002	7741374	2027-08-20	U-1060
N022418-002	7741374	2027-08-20	U-1061
N022418-002	7915247	2027-08-20	U-1000
N022418-002	7915247	2027-08-20	U-1059
N022418-002	7915247	2027-08-20	U-1061

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022418-001	7569612	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741373	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741374	2027-08-20	U-1061		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741374	2027-08-20	U-1060		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7569612	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741373	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741374	2027-08-20	U-1061		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741374	2027-08-20	U-1060		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1061		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7569612	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741373	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741374	2027-08-20	U-1061		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741374	2027-08-20	U-1060		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7569612	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741373	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741374	2027-08-20	U-1061		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741374	2027-08-20	U-1060		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1061		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7569612	2027-08-20	U-1000		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741373	2027-08-20	U-1059		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741374	2027-08-20	U-1061		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741374	2027-08-20	U-1060		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7569612	2027-08-20	U-1000		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741373	2027-08-20	U-1059		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741374	2027-08-20	U-1061		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741374	2027-08-20	U-1060		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7915247	2027-08-20	U-1000		`31067a03dcf5…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRIC ACID	FENOFIBRIC ACID	Leading Pharma, LLC	daa488be-f580-430c-a72c-80ac31bb3e40	2025-08-22	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
FENOFIBRIC ACID	FENOFIBRIC ACID	Aurobindo Pharma Limited	9ad201de-fa62-4c49-bc61-ee09b9ba434c	2025-08-02	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
Fenofibric Acid	FENOFIBRIC ACID	Alembic Pharmaceuticals Inc.	8ffcb173-095a-4550-84f2-18959ad2aab8	2025-07-14	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
Fenofibric acid	FENOFIBRIC ACID	Macleods Pharmaceuticals Limited	af225492-73b0-49bb-b32f-5399c3c3ec6d	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
Fenofibric Acid	FENOFIBRIC ACID	Amneal Pharmaceuticals of New York LLC	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	2025-06-23	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
Fenofibric acid	FENOFIBRIC ACID	Lupin Pharmaceuticals, Inc.	b9a3f97c-9e31-4a5f-822f-c9d45e394493	2023-12-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
Fenofibric Acid	FENOFIBRIC ACID	Alembic Pharmaceuticals Limited	c880d43a-fa8c-4f7a-a488-419bae7cc311	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID
FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Laurus Labs Limited	302ffbf8-448e-4729-949f-40d457e30ab4	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRIC ACID

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13310-101	FIBRICOR	Fenofibric Acid	AR Scientific, Inc.	NDA	Current
13310-102	FIBRICOR	Fenofibric Acid	AR Scientific, Inc.	NDA	Current
49708-101	FIBRICOR	Fenofibric Acid	Caraco Pharma, Inc.	NDA	Current
49708-102	FIBRICOR	Fenofibric Acid	Caraco Pharma, Inc.	NDA	Current
53489-677	Fenofibric Acid	Fenofibric Acid	Mutual Pharmaceutical Company, Inc.	NDA AUTHORIZED GENERIC	Current
53489-678	Fenofibric Acid	Fenofibric Acid	Mutual Pharmaceutical Company, Inc.	NDA AUTHORIZED GENERIC	Current
68134-601	Fenofibric Acid	Fenofibric Acid	Palmetto Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
68134-602	Fenofibric Acid	Fenofibric Acid	Palmetto Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current
69916-035	FIBRICOR	Fenofibric Acid	Tribute Pharmaceuticals US, Inc.	NDA	Current
69916-105	FIBRICOR	Fenofibric Acid	Tribute Pharmaceuticals US, Inc.	NDA	Current
69973-035	Fenofibric Acid	Fenofibric Acid	Halton Laboratories	NDA	Current
69973-105	Fenofibric Acid	Fenofibric Acid	Halton Laboratories	NDA	Current
70347-035	FIBRICOR	Fenofibric Acid	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-105	FIBRICOR	Fenofibric Acid	Aralez Pharmaceuticals US Inc.	NDA	Current
71511-501	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-501	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-501	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-501	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-502	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-502	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-502	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
71511-502	FIBRICOR	Fenofibric Acid	Athena Bioscience, LLC	NDA	Current
72834-035	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-035	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-035	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-035	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-035	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-105	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-105	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-105	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-105	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-105	Fenofibric Acid	Fenofibric Acid	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82511	SUPPL	2025-06-09
82491	SUPPL	2025-06-09
67714	SUPPL	2021-06-07
67706	SUPPL	2021-06-04
60181	SUPPL	2019-10-01
60174	SUPPL	2019-10-01
58759	SUPPL	2019-05-16
54320	SUPPL	2018-05-24
54281	SUPPL	2018-05-21
38685	SUPPL	2014-01-07
7362	SUPPL	2014-01-07
29706	SUPPL	2013-03-19
38684	SUPPL	2013-03-11
7361	SUPPL	2012-12-19
7360	SUPPL	2012-12-19
38683	SUPPL	2012-12-13
17566	SUPPL	2012-12-13
29705	SUPPL	2012-03-19
38682	SUPPL	2012-03-16
7359	SUPPL	2012-01-17
38681	SUPPL	2012-01-06
44750	ORIG	2010-01-05
42518	ORIG	2010-01-05
17565	ORIG	2009-10-01
7358	ORIG	2009-08-21