Application 075868

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	67MG	No	No
002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	134MG	No	No
003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	200MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075868-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	2003-10-27
A075868-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	2003-10-27
A075868-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	2003-10-27

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075868-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075868-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075868-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075868-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075868-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075868-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075868-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075868-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075868-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075868-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075868-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075868-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075868-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075868-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075868-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075868-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075868-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075868-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075868-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075868-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075868-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075868-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075868-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075868-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075868-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075868-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075868-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075868-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075868-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075868-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075868-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075868-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075868-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075868-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075868-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075868-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075868-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075868-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075868-003	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075868-001	AB	1	`3a93d1ddd44b…`

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 2 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals, Inc.	c810b16b-32e2-4d0c-aa28-bf1f62110757	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	e573b3f1-5a4c-4a19-9f0f-ee797b379a08	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Safecor Health, LLC	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	3389b846-8926-3ad5-e063-6294a90aee39	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f443dd79-46da-4b02-8188-7417d39cf975	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Macleods Pharmaceuticals Limited	a504c42a-b629-4a21-a716-084962266b48	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	2f5cee5c-ec55-4e9b-9d54-e7f2f052130e	2026-02-26	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	bdc2211e-6d65-1500-e053-2a95a90ab145	2026-02-20	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	bbeae8e4-e06a-4c19-a1b9-f6143306dab9	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	b79efcf4-6016-4a1f-b83f-be00baa25c21	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bostal LLC	edace25a-3296-9ca7-dcb8-d0698f65840d	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d9c60b43-dc61-4976-b31f-09c8f8a33138	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Glenmark Pharmaceuticals Inc., USA	e7204052-02cf-4b38-835b-d8754c74b2cd	2026-01-31	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvKARE	f669f231-98b9-5014-e053-2a95a90a4e4c	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvKARE	0e240290-f11b-8cc4-e063-6294a90a74f0	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	A-S Medication Solutions	58f0d475-24dc-4f93-aa40-3882b724b70f	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Major Pharmaceuticals	bbffd586-f63a-4a84-bdfb-3e4a1df6449e	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	AvPAK	e949c068-bc7d-3038-e053-2a95a90aee00	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0865c177-b78a-318e-e063-6394a90a318a	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	f2f46239-951d-fc0e-e053-2995a90ae979	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-0511	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0511	Fenofibrate	FENOFIBRATE	Impax Generics	ANDA	Current
0115-0511	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0511	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0511	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0522	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0522	Fenofibrate	FENOFIBRATE	Impax Generics	ANDA	Current
0115-0522	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0522	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0522	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0533	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0533	Fenofibrate	FENOFIBRATE	Impax Generics	ANDA	Current
0115-0533	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0533	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-0533	Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0615-7548	Fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50268-309	Fenofibrate	FENOFIBRATE	AvPAK	ANDA	Current
50268-309	Fenofibrate	FENOFIBRATE	AvPAK	ANDA	Current
50268-309	Fenofibrate	FENOFIBRATE	AvPAK	ANDA	Current
68084-329	Fenofibrate	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-329	Fenofibrate	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-329	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-329	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-329	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-329	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-835	Fenofibrate	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-835	Fenofibrate	FENOFIBRATE	American Health Packaging	ANDA	Current
68084-835	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-835	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-835	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-835	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8814	ORIG	2003-04-10