Application 204019

Type: ANDA
Sponsor: LUPIN 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
A204019-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2015-08-17
A204019-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2015-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204019-001	AB
A204019-002	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	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204019-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2015-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204019-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2015-08-17	`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	A204019-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204019-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204019-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204019-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204019-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204019-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204019-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204019-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204019-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204019-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204019-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204019-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204019-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204019-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204019-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204019-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204019-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204019-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204019-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204019-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204019-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204019-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204019-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204019-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204019-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204019-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204019-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204019-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204019-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204019-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204019-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204019-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204019-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204019-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204019-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204019-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204019-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204019-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204019-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204019-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	4cb6617c-f787-470f-81d8-0aba46df937f	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204019 application number: ANDA204019 ndc (product): 68180-231 ndc (product): 68180-232
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	17edfb43-b708-45cc-9b48-54a4d453adac	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204019 application number: ANDA204019 ndc (product): 50090-6227
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	00c2f942-e839-46fc-948a-f8e2fa79ccd1	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204019 application number: ANDA204019 ndc (product): 50090-5854

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8165	Fenofibrate	Fenofibrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8165	Fenofibrate	Fenofibrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6810	Fenofibrate	Fenofibrate	Major Pharmaceuticals	ANDA	Current
0904-6810	Fenofibrate	Fenofibrate	Major Pharmaceuticals	ANDA	Current
0904-6810	Fenofibrate	Fenofibrate	Major Pharmaceuticals	ANDA	Current
0904-7128	Fenofibrate	Fenofibrate	Major Pharmaceuticals	ANDA	Current
50090-2546	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-2546	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3842	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-3842	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-5854	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
50090-6227	Fenofibrate	Fenofibrate	A-S Medication Solutions	ANDA	Current
63187-681	Fenofibrate	Fenofibrate	Proficient Rx LP	ANDA	Current
63187-681	Fenofibrate	Fenofibrate	Proficient Rx LP	ANDA	Current
68071-2021	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4264	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4264	Fenofibrate	Fenofibrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-231	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-231	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-232	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-232	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-362	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-362	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-362	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-362	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-362	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-363	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-363	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-363	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-363	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-363	Fenofibrate	Fenofibrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-6330	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6330	Fenofibrate	Fenofibrate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0700	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-0700	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-0700	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-0700	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-1988	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-1988	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-1988	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70518-1988	Fenofibrate	Fenofibrate	REMEDYREPACK INC.	ANDA	Current
70934-591	Fenofibrate	Fenofibrate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-366	Fenofibrate	Fenofibrate	Proficient Rx LP	ANDA	Current
72189-026	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current
72189-026	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current
72189-026	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current
72189-026	FENOFIBRATE	FENOFIBRATE	Direct_Rx	ANDA	Current