Application 076433

Type: ANDA
Sponsor: RHODES PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	54MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	160MG	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
A076433-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2005-05-13
A076433-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2005-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076433-001	AB
A076433-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076433-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076433-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076433-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076433-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076433-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076433-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076433-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076433-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076433-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076433-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076433-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076433-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076433-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076433-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076433-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Golden State Medical Supply, Inc.	6dd2e25c-aded-4499-e053-2991aa0a9d60	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433 ndc (product): 51407-094 ndc (product): 51407-093
Fenofibrate	FENOFIBRATE	Rhodes Pharmaceuticals LLC	5e7b79ab-9df0-4bbf-b7a4-a44aec203555	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433 ndc (product): 42858-454 ndc (product): 42858-660
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	40ca5d88-6403-4c4b-ae7f-ae8cec4d9965	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433 ndc (product): 71335-0741
Fenofibrate	FENOFIBRATE	American Health Packaging	66761695-8630-49ff-8264-965dee246437	2025-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	67a0cee0-79be-472a-a2a3-3aee2410b58b	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433 ndc (product): 63629-9474

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-454	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-454	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-454	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-454	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-454	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-454	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-660	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-660	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-660	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-660	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-660	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-660	Fenofibrate	Fenofibrate	Rhodes Pharmaceuticals L.P.	ANDA	Current
50090-3373	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3373	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3373	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
51407-093	Fenofibrate	Fenofibrate	Golden State Medical Supply Inc.	ANDA	Current
51407-093	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-093	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-093	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-093	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-094	Fenofibrate	Fenofibrate	Golden State Medical Supply Inc.	ANDA	Current
51407-094	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-094	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-094	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-094	Fenofibrate	Fenofibrate	Golden State Medical Supply, Inc.	ANDA	Current
60760-660	Fenofibrate	Fenofibrate	St Mary's Medical Park Pharmacy	ANDA	Current
60760-660	Fenofibrate	Fenofibrate	St Mary's Medical Park Pharmacy	ANDA	Current
63629-9474	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current
68071-4289	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4289	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4310	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4310	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7340	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7340	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-298	Fenofibrate	Fenofibrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-298	Fenofibrate	Fenofibrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0741	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-0741	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-0741	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current