Application 205118

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	48MG	No	No
002	FENOFIBRATE	FENOFIBRATE	TABLET;ORAL	145MG	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
A205118-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05
A205118-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205118-001	AB
A205118-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	RS	2016-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205118-001	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-05-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205118-002	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-05-05	`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	A205118-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205118-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205118-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205118-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205118-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205118-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205118-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205118-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205118-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205118-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205118-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205118-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205118-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205118-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205118-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205118-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205118-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205118-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205118-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205118-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205118-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205118-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205118-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205118-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205118-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205118-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205118-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205118-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205118-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205118-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205118-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205118-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205118-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205118-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205118-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205118-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205118-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205118-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205118-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205118-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	bdc2211e-6d65-1500-e053-2a95a90ab145	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205118 application number: ANDA205118 ndc (product): 68071-2369
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	ba8e809e-f6b5-4ba8-9108-81cc82b14225	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205118 application number: ANDA205118 ndc (product): 71335-1701
Fenofibrate	FENOFIBRATE	QUALLENT PHARMACEUTICALS HEALTH LLC	215a5000-9f89-47d9-b2d5-94e13f5e1767	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205118 application number: ANDA205118 ndc (product): 82009-060
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	84fcea7a-05ed-44c2-98fa-7e87b28d2261	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205118 application number: ANDA205118 ndc (product): 65862-769 ndc (product): 65862-768
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d0c7070e-b3bb-4b5b-8a62-4e3136b5accc	2024-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205118 application number: ANDA205118 ndc (product): 50090-3887

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-737	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-737	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-737	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-737	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-738	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-738	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-738	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
16714-738	Fenofibrate	Fenofibrate	NorthStar Rx LLC	ANDA	Current
50090-3887	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3887	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-4957	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
65862-768	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-768	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-768	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-768	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-768	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-769	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-769	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-769	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-769	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
65862-769	Fenofibrate	Fenofibrate	Aurobindo Pharma Limited	ANDA	Current
68071-2369	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4297	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4486	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4983	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4983	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2768	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-2768	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
71335-1701	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-1701	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current
71335-1701	Fenofibrate	Fenofibrate	Bryant Ranch Prepack	ANDA	Current
82009-060	Fenofibrate	Fenofibrate	QUALLENT PHARMACEUTICALS HEALTH LLC	ANDA	Current