Application 209660

Type: ANDA
Sponsor: ORIT LABS LLC

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
A209660-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2019-02-11
A209660-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2019-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209660-001	AB
A209660-002	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	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`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	A209660-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209660-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209660-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209660-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209660-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209660-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209660-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209660-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209660-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209660-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209660-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209660-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209660-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209660-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209660-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209660-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209660-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209660-002	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	Chartwell RX, LLC	cc9d1672-5f82-45a1-b862-859703b3dc37	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	39e61e9d-dda8-4989-a3dd-79545a5c9157	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660 ndc (product): 46708-555 ndc (product): 46708-554
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	4387adac-eea0-40c5-8111-1b70e0d98d7e	2021-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660 ndc (product): 62332-538 ndc (product): 62332-539
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	2985c70d-e85d-483e-8d36-7a4b8454b038	2021-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660 ndc (product): 62332-554 ndc (product): 62332-555

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-554	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-555	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-538	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-538	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-538	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-538	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-539	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-539	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-539	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-539	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-554	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-554	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-554	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-554	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-555	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-555	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-555	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-555	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
68788-7662	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7662	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-638	Fenofibrate	Fenofibrate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current