Application 213842

Type: ANDA
Sponsor: ALEMBIC 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
A213842-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	AB	2020-10-19
A213842-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	AB	2020-10-19
A213842-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	AB	2020-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213842-001	AB
A213842-002	AB
A213842-003	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 3 · 108 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	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A213842-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213842-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213842-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213842-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213842-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213842-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213842-001	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	A-S Medication Solutions	ce403472-6c0c-4854-bb82-ba6539e1ae07	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213842 application number: ANDA213842
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	954753e7-c8d4-487c-b2ad-f90dfb758a92	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213842 application number: ANDA213842 ndc (product): 46708-084 ndc (product): 46708-086 ndc (product): 46708-085
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	d5c046b5-c3fd-4ef3-8245-c93796d4d880	2022-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213842 application number: ANDA213842 ndc (product): 62332-086 ndc (product): 62332-084 ndc (product): 62332-085

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
46708-084	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-085	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-086	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Limited	ANDA	Current
62332-084	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-084	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-084	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-084	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-085	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-085	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-085	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-085	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-086	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-086	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-086	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-086	Fenofibrate	Fenofibrate	Alembic Pharmaceuticals Inc.	ANDA	Current