Application 076520

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	54MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	107MG	No	No
003	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	160MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076520-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	2007-10-25
A076520-002	FENOFIBRATE	FENOFIBRATE	107MG	TABLET / ORAL	2005-12-29
A076520-003	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	2007-10-25

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 4 · 129 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	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076520-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076520-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076520-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076520-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076520-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076520-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076520-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076520-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076520-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076520-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076520-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076520-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076520-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076520-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076520-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076520-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076520-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076520-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076520-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076520-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076520-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076520-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076520-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076520-003	AB	1	`c0c555d07b60…`

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7100	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7100	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7100	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7100	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7100	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7101	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7101	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7101	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7101	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7101	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
42043-170	Fenofibrate	Fenofibrate	Karalex Pharma LLC	ANDA	Current
42043-171	Fenofibrate	Fenofibrate	Karalex Pharma LLC	ANDA	Current
43353-898	Fenofibrate	fenofibrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current