Application 090856

Type: ANDA
Sponsor: LUPIN LTD

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
A090856-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2011-12-23
A090856-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2011-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090856-001	AB
A090856-002	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	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`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	A090856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090856-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090856-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090856-002	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	Major Pharmaceuticals	d9be3ae3-6da9-47fd-bcfd-e561b9d585ca	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	AvPAK	e949c068-bc7d-3038-e053-2a95a90aee00	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856 ndc (product): 50268-338
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0865c177-b78a-318e-e063-6394a90a318a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	45364845-c3b4-40a1-a677-82202ffaa5ad	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856 ndc (product): 68180-389 ndc (product): 68180-388
Fenofibrate	FENOFIBRATE	American Health Packaging	d1f64796-6ba0-415c-a6a0-5456b21a7ed6	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856 ndc (product): 60687-629 ndc (product): 60687-618
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals Inc.	2e6711e9-782d-46bd-9447-6612fe7d0fe7	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3904	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3904	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50268-310	Fenofibrate	Fenofibrate	AvPAK	ANDA	Current
50268-310	Fenofibrate	Fenofibrate	AvPAK	ANDA	Current
50268-311	Fenofibrate	Fenofibrate	AvPAK	ANDA	Current
50268-311	Fenofibrate	Fenofibrate	AvPAK	ANDA	Current
50268-338	Fenofibrate	Fenofibrate	AvPAK	ANDA	Current
57297-360	Fenofibrate	Fenofibrate	LUPIN LIMITED	ANDA	Current
57297-361	Fenofibrate	Fenofibrate	LUPIN LIMITED	ANDA	Current
60687-618	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
60687-618	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
60687-629	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
60687-629	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
60687-629	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-635	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-635	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-635	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-635	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-636	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-636	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-636	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68084-636	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68180-360	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-360	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-360	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-360	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-361	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-361	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-361	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-361	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-388	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-388	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-388	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-389	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-389	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-389	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9301	ORIG	2011-12-29