Application 204598

Type: ANDA
Sponsor: HETERO LABS LTD III

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 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
A204598-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-07-12
A204598-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204598-001	AB
A204598-002	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	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`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	A204598-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204598-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204598-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204598-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204598-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204598-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204598-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204598-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204598-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204598-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204598-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204598-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204598-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204598-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204598-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204598-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204598-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204598-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals, Inc.	c810b16b-32e2-4d0c-aa28-bf1f62110757	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598 ndc (product): 68788-8106
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d9c60b43-dc61-4976-b31f-09c8f8a33138	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598 ndc (product): 50090-3044 ndc (product): 50090-3056
Fenofibrate	FENOFIBRATE	AvKARE	0e240290-f11b-8cc4-e063-6294a90a74f0	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	f04cfe2a-1c06-4a7f-8149-7736a96e8f73	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	8eee54d1-48ca-4704-93f3-0ac6fd7f464e	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	Camber Pharmaceuticals, Inc.	38f43148-4ca0-402a-ba39-8ee5011a7907	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598 ndc (product): 31722-596 ndc (product): 31722-595

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-595	Fenofibrate	Fenofibrate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-596	Fenofibrate	Fenofibrate	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-3044	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3044	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3056	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
68071-2587	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8106	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8106	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-508	Fenofibrate	Fenofibrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-567	Fenofibrate	Fenofibrate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current