Application 022224

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRILIPIX	CHOLINE FENOFIBRATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 45MG FENOFIBRIC ACID	Yes	No
002	TRILIPIX	CHOLINE FENOFIBRATE	CAPSULE, DELAYED RELEASE;ORAL	EQ 135MG FENOFIBRIC ACID	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022224-001	TRILIPIX	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15
N022224-002	TRILIPIX	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15

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 · 84 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
2026-08-18 06:07:40	2026-07	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022224-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022224-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022224-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022224-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022224-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022224-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022224-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022224-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022224-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022224-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022224-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022224-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022224-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022224-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022224-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022224-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022224-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022224-002	AB	1	`8869cabd3fbd…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-001	7259186	2025-01-07	Drug substance	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-002	7259186	2025-01-07	Drug substance	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022224-001	7259186	2025-01-07	Drug substance	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022224-002	7259186	2025-01-07	Drug substance	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-001	7259186	2025-01-07	Drug substance	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-002	7259186	2025-01-07	Drug substance	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-001	7259186	2025-01-07	Drug substance	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-002	7259186	2025-01-07	Drug substance	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-001	7259186	2025-01-07	Drug substance	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-002	7259186	2025-01-07	Drug substance	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-001	7259186	2025-01-07	Drug substance	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-002	7259186	2025-01-07	Drug substance	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-001	7259186	2025-01-07	Drug substance	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-002	7259186	2025-01-07	Drug substance	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-001	7259186	2025-01-07	Drug substance	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-002	7259186	2025-01-07	Drug substance	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022224-001	7259186	2025-01-07	Drug substance	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022224-002	7259186	2025-01-07	Drug substance	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-001	7259186	2025-01-07	Drug substance	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-002	7259186	2025-01-07	Drug substance	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-001	7259186	2025-01-07	Drug substance	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-002	7259186	2025-01-07	Drug substance	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-001	7259186	2025-01-07	Drug substance	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-002	7259186	2025-01-07	Drug substance	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022224-001	7259186	2025-01-07	Drug substance	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022224-002	7259186	2025-01-07	Drug substance	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-001	7259186	2025-01-07	Drug substance	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-002	7259186	2025-01-07	Drug substance	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022224-001	7259186	2025-01-07	Drug substance	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022224-002	7259186	2025-01-07	Drug substance	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022224-001	7259186	2025-01-07	Drug substance	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022224-002	7259186	2025-01-07	Drug substance	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022224-001	7259186	2025-01-07	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022224-002	7259186	2025-01-07	Drug substance	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022224-001	7259186	2025-01-07	Drug substance	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022224-002	7259186	2025-01-07	Drug substance	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022224-001	7259186	2025-01-07	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022224-002	7259186	2025-01-07	Drug substance	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-001	7259186	2025-01-07	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-002	7259186	2025-01-07	Drug substance	`87673890dc5c…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3161	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-3162	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-9189	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-9189	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-9642	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0074-9642	Trilipix	Fenofibric Acid	AbbVie Inc.	NDA	Current
0115-1554	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1554	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1554	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1554	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1554	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1554	Fenofibric Acid	Fenofibric Acid	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1555	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1555	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1555	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1555	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1555	Fenofibric Acid	Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1555	Fenofibric Acid	Fenofibric Acid	Impax Generics	NDA AUTHORIZED GENERIC	Current
50090-4561	Fenofibric Acid	Fenofibric Acid	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4561	Fenofibric Acid	Fenofibric Acid	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
68382-232	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-232	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-232	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-232	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-233	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-233	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-233	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-233	Fenofibric Acid	Fenofibric Acid	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82503	SUPPL	2025-06-09
82487	SUPPL	2025-06-09
67726	SUPPL	2021-06-07
67715	SUPPL	2021-06-07
67708	SUPPL	2021-06-04
67707	SUPPL	2021-06-04
58187	SUPPL	2019-04-02
58140	SUPPL	2019-03-29
56461	SUPPL	2018-11-15
56385	SUPPL	2018-11-08
54302	SUPPL	2018-05-22
54270	SUPPL	2018-05-21
7072	SUPPL	2015-04-28
38409	SUPPL	2015-04-27
29428	SUPPL	2012-09-14
7071	SUPPL	2012-09-14
38408	SUPPL	2012-09-06
17104	SUPPL	2012-09-06
29427	SUPPL	2011-10-03
7070	SUPPL	2011-10-03
38407	SUPPL	2011-09-30
17103	SUPPL	2011-09-30
29426	SUPPL	2011-03-16
38406	SUPPL	2010-09-20
29425	SUPPL	2010-09-16
24262	ORIG	2009-05-28
21963	ORIG	2009-05-28
38405	ORIG	2009-01-02
7069	ORIG	2008-12-19