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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
QuintilesIMS
Fuji
Citi
Boehringer Ingelheim
Accenture
Colorcon
Argus Health
Baxter

Generated: May 21, 2018

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, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla Ltd, Cnty Line Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mylan, Mylan Pharms Inc, Rhodes Pharms, Valeant Pharms North, Amerigen Pharms Ltd, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Invagen Pharms, and is included in twenty-seven NDAs. It is available from thirty-three 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:FENOFIBRATE
Applicant:Sun Pharm Inds Ltd
Ingredient:fenofibrate
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 N 42291-292-90
FENOFIBRATE fenofibrate CAPSULE;ORAL 201748 ANDA Ranbaxy Pharmaceuticals Inc. 63304-443 N 63304-443-05

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Covington
Mallinckrodt
Fish and Richardson
Daiichi Sankyo
Medtronic
McKinsey
Cipla
Teva

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