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 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
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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075868-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2003-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075868-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2003-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075868-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2003-10-27	`caaa826d4ba7…`
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…`

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 7 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	954753e7-c8d4-487c-b2ad-f90dfb758a92	2023-01-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Laurus Labs Limited	0da6d56e-1ed6-437d-b88d-16b014d1889a	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	8e58c13a-8088-4fed-86cc-52530de5aa45	2022-12-28	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	Proficient Rx LP	b9a6866c-9dbe-4419-bcad-52ec0127821f	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Proficient Rx LP	26f8f793-fb7a-4327-9441-d8737fe1ff11	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	d5c046b5-c3fd-4ef3-8245-c93796d4d880	2022-05-12	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Proficient Rx LP	41f0f514-1fa9-47a0-a085-a31354842f96	2022-03-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	4387adac-eea0-40c5-8111-1b70e0d98d7e	2021-11-16	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	2985c70d-e85d-483e-8d36-7a4b8454b038	2021-11-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	05957860-eab3-4172-9877-455540d0c922	2021-09-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	fa08cf6a-d306-4979-9b23-ac7febf4fd12	2021-04-01	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	7e79d495-5d59-485e-b3c2-7c31ba044948	2021-03-30	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Inc.	9e69d844-5ded-46b6-8321-c420e8b37a63	2021-03-24	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	1e56492f-e2b1-4a07-b697-b59b3a0ac05e	2021-02-24	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	fafbc0be-f0ba-4dcd-8aa5-89527bae5e84	2019-03-08	Warnings, Adverse reactions	Name fallback generic name: FENOFIBRATE
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Limited	16ea8ce4-8c1c-4111-509e-86aa688d89a0	2018-12-28	Warnings, Adverse reactions	Name fallback 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 · 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