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Serving leading biopharmaceutical companies globally:

Baxter
Argus Health
Fish and Richardson
AstraZeneca
Chinese Patent Office
Novartis
Merck
US Army
McKinsey
Medtronic

Generated: December 16, 2017

DrugPatentWatch Database Preview

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 three suppliers. 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:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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 H2-Pharma, LLC 61269-210 61269-210-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-210-90)
LIPOFEN fenofibrate CAPSULE;ORAL 021612 NDA H2-Pharma, LLC 61269-212 61269-212-90 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-212-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 11, 2006TE:RLD:Yes

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 021612

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cipher Pharms IncLIPOFENfenofibrateCAPSULE;ORAL021612-001Jan 11, 2006► Subscribe► Subscribe
Cipher Pharms IncLIPOFENfenofibrateCAPSULE;ORAL021612-003Jan 11, 2006► Subscribe► Subscribe
Cipher Pharms IncLIPOFENfenofibrateCAPSULE;ORAL021612-002Jan 11, 2006► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cerilliant
Moodys
Chinese Patent Office
Baxter
Cantor Fitzgerald
Queensland Health
Deloitte
Argus Health
Covington

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