Application 205566

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	67MG	No	No
002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	134MG	No	No
003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205566-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	AB	2017-04-07
A205566-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	AB	2017-04-07
A205566-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	AB	2017-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205566-001	AB
A205566-002	AB
A205566-003	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 4 · 123 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	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205566-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2017-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205566-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2017-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205566-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2017-04-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A205566-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205566-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205566-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205566-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205566-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205566-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205566-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205566-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205566-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205566-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205566-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205566-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205566-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205566-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205566-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205566-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205566-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205566-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205566-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205566-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205566-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205566-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205566-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205566-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205566-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205566-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205566-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205566-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205566-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205566-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205566-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205566-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205566-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205566-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205566-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205566-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205566-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205566-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205566-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205566-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	American Health Packaging	8b4488f4-bef6-408c-9fca-3e4aebceff9a	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205566 application number: ANDA205566 ndc (product): 60687-713
fenofibrate	FENOFIBRATE	Glenmark Pharmaceuticals Inc., USA	e7204052-02cf-4b38-835b-d8754c74b2cd	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205566 application number: ANDA205566 ndc (product): 68462-581 ndc (product): 68462-582 ndc (product): 68462-580
fenofibrate	FENOFIBRATE	A-S Medication Solutions	9d284236-c788-4e9e-8573-4d119e45d3b9	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205566 application number: ANDA205566 ndc (product): 50090-6120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6120	fenofibrate	fenofibrate	A-S Medication Solutions	ANDA	Current
60687-713	Fenofibrate	Fenofibrate	American Health Packaging	ANDA	Current
68462-580	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-580	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-580	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-580	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-580	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-580	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-581	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-581	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-581	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-581	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-581	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-581	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-582	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-582	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-582	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-582	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-582	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-582	fenofibrate	fenofibrate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current