Application 210138

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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
A210138-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2018-07-23
A210138-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210138-001	AB
A210138-002	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	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`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	A210138-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210138-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210138-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210138-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210138-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210138-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210138-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210138-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210138-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210138-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210138-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210138-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210138-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210138-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210138-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210138-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210138-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210138-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1ad55-c449-4250-a666-bb36a6ff5b53	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 71335-1286
fenofibrate	FENOFIBRATE	A-S Medication Solutions	58f0d475-24dc-4f93-aa40-3882b724b70f	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 50090-5244
fenofibrate	FENOFIBRATE	Ajanta Pharma USA Inc.	eb400ea7-bbd8-440b-b8be-082121621408	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 27241-117 ndc (product): 27241-116
fenofibrate	FENOFIBRATE	Quality Care Products, LLC	d1fb3b66-cac9-49cd-a9f8-c4ce960f66e7	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 55700-876
fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	8e9898d1-1fc0-b7c6-e053-2a95a90a65cd	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 68071-4991
fenofibrate	FENOFIBRATE	Proficient Rx LP	b9a6866c-9dbe-4419-bcad-52ec0127821f	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 71205-190
fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	fafbc0be-f0ba-4dcd-8aa5-89527bae5e84	2019-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (product): 0615-8270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8270	fenofibrate	fenofibrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
27241-116	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-116	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-116	fenofibrate	fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-116	fenofibrate	fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-116	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-116	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-117	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-117	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-117	fenofibrate	fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-117	fenofibrate	fenofibrate	Ajanta Pharma USA Inc.	ANDA	Current
27241-117	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
27241-117	fenofibrate	fenofibrate	Ajanta Pharma Limited	ANDA	Current
50090-5244	fenofibrate	fenofibrate	A-S Medication Solutions	ANDA	Current
50090-5244	fenofibrate	fenofibrate	A-S Medication Solutions	ANDA	Current
55700-876	fenofibrate	fenofibrate	Quality Care Products, LLC	ANDA	Current
55700-876	fenofibrate	fenofibrate	Quality Care Products, LLC	ANDA	Current
60760-411	fenofibrate	fenofibrate	St. Mary's Medical Park Pharmacy	ANDA	Current
68071-4991	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4991	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4992	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4992	fenofibrate	fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7578	fenofibrate	fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7578	fenofibrate	fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7578	fenofibrate	fenofibrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2349	fenofibrate	fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-2349	fenofibrate	fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-2349	fenofibrate	fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-2349	fenofibrate	fenofibrate	REMEDYREPACK INC.	ANDA	Current
71205-190	fenofibrate	fenofibrate	Proficient Rx LP	ANDA	Current
71205-190	fenofibrate	fenofibrate	Proficient Rx LP	ANDA	Current
71205-190	fenofibrate	fenofibrate	Proficient Rx LP	ANDA	Current
71335-1286	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-1286	fenofibrate	fenofibrate	Bryant Ranch Prepack	ANDA	Current
72189-172	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current
72189-172	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current
72189-172	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current