Application 207803

Type: ANDA
Sponsor: AUSTARPHARMA

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
A207803-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2017-12-19
A207803-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2017-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207803-001	AB
A207803-002	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	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207803-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2017-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207803-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2017-12-19	`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	A207803-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207803-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207803-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207803-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207803-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207803-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207803-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207803-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207803-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207803-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207803-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207803-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207803-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207803-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207803-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207803-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207803-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207803-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207803-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207803-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207803-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207803-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207803-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207803-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207803-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207803-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207803-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207803-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207803-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207803-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207803-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207803-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207803-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207803-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207803-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207803-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207803-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207803-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207803-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207803-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Westminster Pharmaceuticals, LLC	a97ebf51-4f68-4426-9958-5c59f91b1d47	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207803 application number: ANDA207803 ndc (product): 69367-257 ndc (product): 69367-254
Fenofibrate	FENOFIBRATE	Bostal LLC	edace25a-3296-9ca7-dcb8-d0698f65840d	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207803 application number: ANDA207803 ndc (product): 35561-343 ndc (product): 35561-344
Fenofibrate	FENOFIBRATE	AvKARE	f669f231-98b9-5014-e053-2a95a90a4e4c	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207803 application number: ANDA207803
Fenofibrate	FENOFIBRATE	Proficient Rx LP	41f0f514-1fa9-47a0-a085-a31354842f96	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207803 application number: ANDA207803 ndc (product): 71205-949

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
35561-343	Fenofibrate	Fenofibrate	AustarPharma LLC	ANDA	Current
35561-344	Fenofibrate	Fenofibrate	AustarPharma LLC	ANDA	Current
69367-254	Fenofibrate	Fenofibrate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-254	Fenofibrate	Fenofibrate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-254	Fenofibrate	Fenofibrate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-257	Fenofibrate	Fenofibrate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-257	Fenofibrate	Fenofibrate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-257	Fenofibrate	Fenofibrate	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-949	Fenofibrate	Fenofibrate	Proficient Rx LP	ANDA	Current
71205-949	Fenofibrate	Fenofibrate	Proficient Rx LP	ANDA	Current