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 6 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	968e7f57-1360-ba5a-e053-2995a90a206c	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	8e9898d1-1fc0-b7c6-e053-2a95a90a65cd	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	17edfb43-b708-45cc-9b48-54a4d453adac	2024-04-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	00c2f942-e839-46fc-948a-f8e2fa79ccd1	2024-04-29	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Tricor	FENOFIBRATE	A-S Medication Solutions	84b2af1b-365e-4723-ac5f-bc826ec47772	2024-04-29	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	dd98e467-ecb3-463c-81d8-8b4d89159ab0	2024-02-27	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	67a0cee0-79be-472a-a2a3-3aee2410b58b	2024-01-12	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d0c7070e-b3bb-4b5b-8a62-4e3136b5accc	2024-01-07	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	3f2b3a16-7735-487e-9a2c-e078a18df1bc	2024-01-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f937a176-3d3e-4dc6-a7d4-c1a4749c7a7f	2023-12-27	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	f3af845c-ce4e-4bf2-82e7-7753c9088645	2023-12-07	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1daf6-1f0e-4464-b160-7c10c492a570	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	A-S Medication Solutions	9d284236-c788-4e9e-8573-4d119e45d3b9	2023-11-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	734f72a2-96f7-4480-9a87-c1ffd94b5f0b	2023-07-26	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	06870192-c92a-40c7-a619-efda0c006301	2023-04-19	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5	2023-03-31	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	65ca643c-3b31-4e53-bc06-0e11418baf7d	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	39e61e9d-dda8-4989-a3dd-79545a5c9157	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Alembic Pharmaceuticals Limited	ddafb483-bae5-49bf-845d-67c29e6dc12d	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Cipla USA Inc.,	07d47c02-ab29-4ba9-aea0-96ffbd70c0ef	2023-01-20	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