Application 209951

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	48MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	145MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209951-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2018-02-09
A209951-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2018-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209951-001	AB
A209951-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209951-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2018-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209951-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2018-02-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209951-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209951-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209951-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209951-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209951-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209951-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209951-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209951-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209951-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209951-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209951-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209951-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209951-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209951-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209951-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209951-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209951-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209951-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209951-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209951-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209951-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209951-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209951-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209951-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209951-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209951-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209951-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209951-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209951-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209951-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209951-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209951-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209951-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209951-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209951-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209951-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209951-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209951-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209951-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209951-002	AB	1	`74a2ff9319b5…`

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	AvKARE	44efa0d1-19d6-9696-e063-6394a90a068d	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209951 application number: ANDA209951
Fenofibrate	FENOFIBRATE	Amneal Pharmaceuticals NY LLC	283e754e-6ffa-4d6a-882f-9bbb3cbc8ca8	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209951 application number: ANDA209951 ndc (product): 69238-1261 ndc (product): 69238-1260

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1260	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1260	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1260	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1260	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1260	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1260	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1261	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1261	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1261	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1261	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1261	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1261	Fenofibrate	Fenofibrate	Amneal Pharmaceuticals LLC	ANDA	Current