Application 076509

Type: ANDA
Sponsor: IMPAX LABS

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	160MG	No	Yes

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
A076509-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26
A076509-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076509-001	AB
A076509-002	AB

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076509-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076509-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076509-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076509-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076509-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076509-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076509-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076509-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076509-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076509-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076509-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076509-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076509-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076509-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076509-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076509-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076509-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076509-002	AB	1	`782e0a99824c…`

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
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals LLC	65f5dcad-5073-4347-9ec9-e7f350b134c4	2026-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509 ndc (product): 60219-5522 ndc (product): 60219-5511
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	4b4447a1-8136-4258-b2c8-c5f9c1bcec92	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509 ndc (product): 51655-009
FENOFIBRATE	FENOFIBRATE	AvPAK	d4e1d692-3c03-7406-ee06-7a6fb39ed3e7	2025-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509 ndc (product): 50268-313 ndc (product): 50268-312
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	882ee82a-3c56-4173-af42-68c3aadc8aa7	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	35ba17d9-0dd7-4f15-8f74-be5fd15f1917	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	3f2b3a16-7735-487e-9a2c-e078a18df1bc	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f937a176-3d3e-4dc6-a7d4-c1a4749c7a7f	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	fa08cf6a-d306-4979-9b23-ac7febf4fd12	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509 ndc (product): 0115-5522 ndc (product): 0115-5511

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-5511	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5511	FENOFIBRATE	FENOFIBRATE	Impax Generics	ANDA	Current
0115-5511	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5511	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5511	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5511	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5522	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5522	FENOFIBRATE	FENOFIBRATE	Impax Generics	ANDA	Current
0115-5522	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5522	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5522	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-5522	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0179-0091	FENOFIBRATE	FENOFIBRATE	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-0103	FENOFIBRATE	FENOFIBRATE	KAISER FOUNDATION HOSPITALS	ANDA	Current
33261-966	FENOFIBRATE	FENOFIBRATE	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-916	FENOFIBRATE	FENOFIBRATE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-916	FENOFIBRATE	FENOFIBRATE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42291-289	FENOFIBRATE	FENOFIBRATE	AvKARE, Inc.	ANDA	Current
42291-289	FENOFIBRATE	FENOFIBRATE	AvKARE, Inc.	ANDA	Current
42291-289	FENOFIBRATE	FENOFIBRATE	AvKARE	ANDA	Current
42291-289	FENOFIBRATE	FENOFIBRATE	AvKARE	ANDA	Current
42291-290	FENOFIBRATE	FENOFIBRATE	AvKARE, Inc.	ANDA	Current
42291-290	FENOFIBRATE	FENOFIBRATE	AvKARE, Inc.	ANDA	Current
42291-290	FENOFIBRATE	FENOFIBRATE	AvKARE	ANDA	Current
42291-290	FENOFIBRATE	FENOFIBRATE	AvKARE	ANDA	Current
50090-1274	FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	ANDA	Current
50090-1274	FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	ANDA	Current
50090-1274	FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	ANDA	Current
50268-312	FENOFIBRATE	FENOFIBRATE	AvPAK	ANDA	Current
50268-312	FENOFIBRATE	FENOFIBRATE	AvPAK	ANDA	Current
50268-312	FENOFIBRATE	FENOFIBRATE	AvPAK	ANDA	Current
50268-313	FENOFIBRATE	FENOFIBRATE	AvPAK	ANDA	Current
50268-313	FENOFIBRATE	FENOFIBRATE	AvPAK	ANDA	Current
50268-313	FENOFIBRATE	FENOFIBRATE	AvPAK	ANDA	Current
51655-009	Fenofibrate	Fenofibrate	Northwind Pharmaceuticals	ANDA	Current
60219-5511	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-5522	FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	ANDA	Current
63629-7151	FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	ANDA	Current
63629-7151	FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	ANDA	Current
68084-328	FENOFIBRATE	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-328	FENOFIBRATE	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-328	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-328	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-827	FENOFIBRATE	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-827	FENOFIBRATE	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-827	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-827	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
70934-223	FENOFIBRATE	FENOFIBRATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-223	FENOFIBRATE	FENOFIBRATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-223	FENOFIBRATE	FENOFIBRATE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current