Application 210705

Type: ANDA
Sponsor: AJANTA PHARMA 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	RLD / RS	Approval date
A210705-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	AB		2018-09-10
A210705-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	AB		2018-09-10
A210705-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	AB	RS	2018-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210705-001	AB
A210705-002	AB
A210705-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210705-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB		2018-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210705-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	RS	2018-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210705-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB		2018-09-10	`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	A210705-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210705-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210705-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210705-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210705-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210705-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210705-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210705-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210705-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210705-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210705-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210705-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210705-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210705-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210705-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210705-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210705-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210705-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210705-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210705-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210705-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210705-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210705-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210705-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210705-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210705-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210705-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210705-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210705-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210705-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210705-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210705-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210705-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210705-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210705-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210705-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210705-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210705-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210705-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210705-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Ajanta Pharma USA Inc.	da2f0ba4-7c16-4fb0-bc1c-45540e8fefbf	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210705 application number: ANDA210705 ndc (product): 27241-118 ndc (product): 27241-119 ndc (product): 27241-120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-118	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-118	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-118	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-118	Fenofibrate	Fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-118	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-119	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-119	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-119	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-119	Fenofibrate	Fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-119	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-120	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-120	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-120	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-120	Fenofibrate	Fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-120	Fenofibrate	Fenofibrate	Ajanta Pharma Limited	ANDA	Current