Application 202856

Type: ANDA
Sponsor: MYLAN PHARMS INC

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
A202856-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2012-12-07
A202856-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2012-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202856-001	AB
A202856-002	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	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`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	A202856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202856-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202856-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202856-002	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	Safecor Health, LLC	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	0f958942-1504-40a1-8ad8-43df2c3f717e	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856 ndc (product): 0378-3066 ndc (product): 0378-3065
Fenofibrate	FENOFIBRATE	Mylan Institutional Inc.	5a90e0a4-7892-462f-9776-037d23a93b10	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856 ndc (product): 51079-608 ndc (product): 51079-599
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	43aa7e51-443c-4ea0-abf2-f7d9378b3ba9	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	dd98e467-ecb3-463c-81d8-8b4d89159ab0	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1daf6-1f0e-4464-b160-7c10c492a570	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856 ndc (product): 71335-2016

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3065	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3065	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3065	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3065	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3066	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3066	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3066	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3066	Fenofibrate	fenofibrate	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-599	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-599	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-599	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-599	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-599	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-608	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-608	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-608	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-608	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
51079-608	Fenofibrate	fenofibrate	Mylan Institutional Inc.	ANDA	Current
68071-2686	Fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7932	Fenofibrate	fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7932	Fenofibrate	fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-2016	Fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current