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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 021612

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NDA 021612 describes LIPOFEN, which is a drug marketed by Cipher Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the LIPOFEN profile page.

The generic ingredient in LIPOFEN is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 021612

Tradename:	LIPOFEN
Applicant:	Cipher Pharms Inc
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 021612

Medical Subject Heading (MeSH) Categories for 021612

Hypolipidemic Agents

Suppliers and Packaging for NDA: 021612

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIPOFEN	fenofibrate	CAPSULE;ORAL	021612	NDA	ANI Pharmaceuticals, Inc.	62559-305	62559-305-90	90 CAPSULE in 1 BOTTLE (62559-305-90)
LIPOFEN	fenofibrate	CAPSULE;ORAL	021612	NDA	ANI Pharmaceuticals, Inc.	62559-306	62559-306-90	90 CAPSULE in 1 BOTTLE (62559-306-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jan 11, 2006	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jan 11, 2006	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	150MG
Approval Date:	Jan 11, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021612

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006	5,545,628	⤷ Get Started Free
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006	5,545,628	⤷ Get Started Free
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006	5,545,628	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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