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Last Updated: November 4, 2024

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-four 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
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:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 11, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 11, 2006TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 11, 2006TE:RLD:Yes

Expired US Patents for NDA 021612

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-001 Jan 11, 2006 ⤷  Sign Up ⤷  Sign Up
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-003 Jan 11, 2006 ⤷  Sign Up ⤷  Sign Up
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-002 Jan 11, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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