Application 090715

Type: ANDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	48MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	145MG	No	No

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
A090715-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL			2012-04-05
A090715-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL			2012-04-05

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL		2012-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL		2012-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL		2012-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL		2012-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-04-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-04-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A090715-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090715-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090715-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090715-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090715-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090715-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090715-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090715-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090715-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090715-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090715-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090715-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090715-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090715-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090715-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090715-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090715-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090715-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090715-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090715-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090715-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090715-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090715-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090715-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090715-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090715-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090715-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090715-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090715-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090715-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090715-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090715-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090715-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090715-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090715-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090715-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090715-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090715-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090715-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090715-002	AB	1	`5aa47cf7b7d7…`

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	REMEDYREPACK INC.	3b6c5ebd-a8bc-4502-8b66-f4e58914815b	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Major Pharmaceuticals	d9be3ae3-6da9-47fd-bcfd-e561b9d585ca	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	American Health Packaging	8b4488f4-bef6-408c-9fca-3e4aebceff9a	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bostal LLC	7eb328d0-4e6f-4b24-ae85-68c2b3657569	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Sun Pharmaceutical Industries, Inc.	2083f5d9-92f2-4c64-b996-fabbd6946ea0	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Golden State Medical Supply, Inc.	6dd2e25c-aded-4499-e053-2991aa0a9d60	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1ad55-c449-4250-a666-bb36a6ff5b53	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	ce403472-6c0c-4854-bb82-ba6539e1ae07	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals LLC	65f5dcad-5073-4347-9ec9-e7f350b134c4	2026-06-06	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	St. Mary's Medical Park Pharmacy	b92fb19a-d0df-426e-e053-2995a90ab379	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	fa9deae7-6cbf-4559-8130-b86b23b6d0ec	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Rhodes Pharmaceuticals LLC	5e7b79ab-9df0-4bbf-b7a4-a44aec203555	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	b11f1c74-23da-4273-b504-0a2ca22c4b5a	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Westminster Pharmaceuticals, LLC	a97ebf51-4f68-4426-9958-5c59f91b1d47	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate 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 brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	df9f67d6-3cd9-4f44-8020-2d6ef53c30b5	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bostal LLC	a5bc232c-ff27-f8b6-e053-2995a90ad399	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Golden State Medical Supply, Inc.	3e611f91-e351-9558-e063-6394a90ace17	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals, Inc.	c810b16b-32e2-4d0c-aa28-bf1f62110757	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-132	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-132	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-132	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-132	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-132	fenofibrate	fenofibrate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-132	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-315	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-315	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-315	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-315	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
45802-315	fenofibrate	fenofibrate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-315	fenofibrate	fenofibrate	Perrigo New York Inc	ANDA	Current
50090-2459	fenofibrate	fenofibrate	A-S Medication Solutions	ANDA	Current
50090-2692	fenofibrate	fenofibrate	A-S Medication Solutions	ANDA	Current
68071-3114	fenofibrate	fenofibrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3114	fenofibrate	fenofibrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4182	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4182	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4265	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4320	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4320	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4358	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4358	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7254	fenofibrate	fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7254	fenofibrate	fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7254	fenofibrate	fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-050	fenofibrate	fenofibrate	Proficient Rx LP	ANDA	Current
71205-050	fenofibrate	fenofibrate	Proficient Rx LP	ANDA	Current
71335-0578	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-0578	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-0903	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-0903	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-0903	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
71610-027	fenofibrate	fenofibrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current