Application 209504

Type: ANDA
Sponsor: ANI PHARMS INC

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	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A209504-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	AB	2018-04-30
A209504-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	AB	2018-04-30
A209504-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	AB	2018-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209504-001	AB
A209504-002	AB
A209504-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209504-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209504-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209504-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209504-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209504-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	ANI Pharmaceuticals, Inc.	c740f57c-cac5-4526-a5a9-aaab65b1caf6	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209504 application number: ANDA209504 ndc (product): 43975-305 ndc (product): 43975-306 ndc (product): 43975-444
Fenofibrate	FENOFIBRATE	Coupler LLC	3134b274-5dc0-cf90-e063-6294a90a252b	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209504 application number: ANDA209504

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43975-305	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-305	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-305	Fenofibrate	Fenofibrate	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-305	Fenofibrate	Fenofibrate	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-305	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-306	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-306	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-306	Fenofibrate	Fenofibrate	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-306	Fenofibrate	Fenofibrate	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-306	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-444	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-444	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-444	Fenofibrate	Fenofibrate	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-444	Fenofibrate	Fenofibrate	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-444	Fenofibrate	Fenofibrate	ANI Pharmaceuticals, Inc.	ANDA	Current
68071-2812	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current