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Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Chinese Patent Office
US Army

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

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
Chinese Patent Office
Cantor Fitzgerald
Queensland Health
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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