Application 021612

Type: NDA
Sponsor: CIPHER PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIPOFEN	FENOFIBRATE	CAPSULE;ORAL	50MG	Yes	No
002	LIPOFEN	FENOFIBRATE	CAPSULE;ORAL	100MG	No	No
003	LIPOFEN	FENOFIBRATE	CAPSULE;ORAL	150MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N021612-001	LIPOFEN	FENOFIBRATE	50MG	CAPSULE / ORAL	RLD	2006-01-11
N021612-002	LIPOFEN	FENOFIBRATE	100MG	CAPSULE / ORAL	RLD	2006-01-11
N021612-003	LIPOFEN	FENOFIBRATE	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`c0c555d07b60…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lipofen	FENOFIBRATE	ANI Pharmaceuticals, Inc.	78b789b9-854f-46b9-97f3-a48759a6ff89	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021612 application number: NDA021612 ndc (product): 62559-306 ndc (product): 62559-305
Fenofibrate	FENOFIBRATE	ANI Pharmaceuticals, Inc.	3a69e15a-eda6-4a6e-8934-6881e4370521	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021612 application number: NDA021612 ndc (product): 62559-461 ndc (product): 62559-460

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61269-210	Fenofibrate	fenofibrate	H2-Pharma, LLC	NDA	Current
61269-212	Fenofibrate	fenofibrate	H2-Pharma, LLC	NDA	Current
62559-305	Lipofen	fenofibrate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-306	Lipofen	fenofibrate	ANI Pharmaceuticals, Inc.	NDA	Current
62559-460	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-460	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-460	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-460	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-461	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-461	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-461	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
62559-461	Fenofibrate	fenofibrate	ANI Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
66869-137	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America Inc.	NDA	Current
66869-137	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America Inc.	NDA	Current
66869-137	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-137	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-147	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America Inc.	NDA	Current
66869-147	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America Inc.	NDA	Current
66869-147	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-147	LIPOFEN	fenofibrate	Kowa Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82500	SUPPL	2025-06-09
82489	SUPPL	2025-06-09
67720	SUPPL	2021-06-07
67703	SUPPL	2021-06-04
58758	SUPPL	2019-05-16
58746	SUPPL	2019-05-16
56457	SUPPL	2018-11-15
56384	SUPPL	2018-11-08
54280	SUPPL	2018-05-21
54279	SUPPL	2018-05-21
37338	SUPPL	2013-01-23
28246	SUPPL	2013-01-23
15876	SUPPL	2013-01-23
5856	SUPPL	2013-01-23
5855	SUPPL	2011-11-02
15875	SUPPL	2011-10-31
28245	SUPPL	2008-12-19
5854	SUPPL	2008-12-19
42233	ORIG	2008-11-17
15874	ORIG	2006-01-24
5853	ORIG	2006-01-24