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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL		2012-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL		2012-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090715-001	FENOFIBRATE	48MG	TABLET / ORAL		2012-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090715-002	FENOFIBRATE	145MG	TABLET / ORAL		2012-04-05	`caaa826d4ba7…`
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…`

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 7 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	954753e7-c8d4-487c-b2ad-f90dfb758a92	2023-01-16	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Laurus Labs Limited	0da6d56e-1ed6-437d-b88d-16b014d1889a	2022-12-28	Warnings, Adverse reactions	Name fallback brand name: fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	8e58c13a-8088-4fed-86cc-52530de5aa45	2022-12-28	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Proficient Rx LP	b9a6866c-9dbe-4419-bcad-52ec0127821f	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Proficient Rx LP	26f8f793-fb7a-4327-9441-d8737fe1ff11	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	d5c046b5-c3fd-4ef3-8245-c93796d4d880	2022-05-12	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Proficient Rx LP	41f0f514-1fa9-47a0-a085-a31354842f96	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	4387adac-eea0-40c5-8111-1b70e0d98d7e	2021-11-16	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	2985c70d-e85d-483e-8d36-7a4b8454b038	2021-11-08	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	05957860-eab3-4172-9877-455540d0c922	2021-09-08	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	fa08cf6a-d306-4979-9b23-ac7febf4fd12	2021-04-01	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	7e79d495-5d59-485e-b3c2-7c31ba044948	2021-03-30	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Inc.	9e69d844-5ded-46b6-8321-c420e8b37a63	2021-03-24	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	1e56492f-e2b1-4a07-b697-b59b3a0ac05e	2021-02-24	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	fafbc0be-f0ba-4dcd-8aa5-89527bae5e84	2019-03-08	Warnings, Adverse reactions	Name fallback brand name: fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Limited	16ea8ce4-8c1c-4111-509e-86aa688d89a0	2018-12-28	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE

Reported adverse events (FAERS/openFDA)#

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

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