Application 217732

Type: ANDA
Sponsor: CREEKWOOD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	40MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	120MG	No	No

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

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
A217732-001	FENOFIBRATE	FENOFIBRATE	40MG	TABLET / ORAL	AB		2023-09-07
A217732-002	FENOFIBRATE	FENOFIBRATE	120MG	TABLET / ORAL	AB		2023-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217732-001	AB
A217732-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	BX	2023-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	BX	2023-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217732-001	FENOFIBRATE	40MG	TABLET / ORAL	AB	2023-09-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217732-002	FENOFIBRATE	120MG	TABLET / ORAL	AB	2023-09-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217732-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217732-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217732-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217732-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217732-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217732-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217732-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217732-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217732-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217732-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217732-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217732-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217732-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217732-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217732-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217732-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217732-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217732-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217732-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217732-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217732-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217732-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217732-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217732-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217732-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217732-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217732-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217732-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217732-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217732-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217732-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217732-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217732-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217732-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217732-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217732-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217732-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217732-002	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217732-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217732-002	AB	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	3389b846-8926-3ad5-e063-6294a90aee39	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217732 application number: ANDA217732
FENOFIBRATE	FENOFIBRATE	Creekwood Pharmaceuticals LLC	65d8aefc-7ec2-4f62-9254-5f0070c58ac2	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217732 application number: ANDA217732
FENOFIBRATE	FENOFIBRATE	Trifluent Pharma LLC	3c3539e4-bc4a-8152-e063-6294a90ab55c	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217732 application number: ANDA217732
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	338d03b2-c34e-6e24-e063-6394a90a3c39	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217732 application number: ANDA217732