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Serving leading biopharmaceutical companies globally:

US Army
AstraZeneca
Cantor Fitzgerald
Dow
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Express Scripts
Johnson and Johnson
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Merck
Teva

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201748

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NDA 201748 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mylan, Mylan Pharms Inc, Rhodes Pharms, Valeant Pharms North, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-two NDAs. It is available from thirty-five suppliers. Additional details are available on the FENOFIBRATE profile page.

The generic ingredient in FENOFIBRATE 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 201748

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201748

Medical Subject Heading (MeSH) Categories for 201748

Suppliers and Packaging for NDA: 201748

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE fenofibrate CAPSULE;ORAL 201748 ANDA AvKARE, Inc. 42291-292 42291-292-90 90 CAPSULE in 1 BOTTLE (42291-292-90)
FENOFIBRATE fenofibrate CAPSULE;ORAL 201748 ANDA Ranbaxy Pharmaceuticals Inc. 63304-443 63304-443-05 500 CAPSULE in 1 BOTTLE (63304-443-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Oct 31, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Oct 31, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
Teva
Fish and Richardson
Harvard Business School
Deloitte
Julphar
Mallinckrodt
Express Scripts
Colorcon
Chubb

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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