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 3 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	AvPAK	e949c068-bc7d-3038-e053-2a95a90aee00	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0865c177-b78a-318e-e063-6394a90a318a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	f2f46239-951d-fc0e-e053-2995a90ae979	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	f7590970-c54d-24e9-e053-6294a90ac400	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0178ea2e-2c79-b97b-e063-6394a90ac145	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	f2b6e2a7-68d7-264d-e053-2a95a90aa9d1	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	4b4447a1-8136-4258-b2c8-c5f9c1bcec92	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Chartwell RX, LLC.	2d0cfddc-ace3-4187-8d94-d760d23d20b6	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvKARE	44efa0d1-19d6-9696-e063-6394a90a068d	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Ajanta Pharma USA Inc.	eb400ea7-bbd8-440b-b8be-082121621408	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Solco Healthcare US, LLC	085109a6-f006-44f0-a170-980d8899a365	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	4cb6617c-f787-470f-81d8-0aba46df937f	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	45364845-c3b4-40a1-a677-82202ffaa5ad	2025-11-19	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	AvPAK	d4e1d692-3c03-7406-ee06-7a6fb39ed3e7	2025-11-16	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Apotex Corp.	68024459-987a-9cf4-f539-4959093bc9f0	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	f04cfe2a-1c06-4a7f-8149-7736a96e8f73	2025-10-24	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	db3ac584-2c8e-4f69-b24c-96ddcca2c23f	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d26e21bf-6c54-437d-81fe-07220e450561	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Fenofibrate generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Creekwood Pharmaceuticals LLC	65d8aefc-7ec2-4f62-9254-5f0070c58ac2	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: FENOFIBRATE generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Cipla USA Inc.	f8f09ab1-74db-4123-b85a-6337dc2582a0	2025-10-06	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