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Dow
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Mallinckrodt
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090859

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NDA 090859 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Apotex Inc, Cnty Line Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, and Rhodes Pharms, and is included in nine NDAs. It is available from eighteen suppliers. Additional details are available on the FENOFIBRATE (MICRONIZED) profile page.

The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 090859
Tradename:FENOFIBRATE (MICRONIZED)
Applicant:Dr Reddys Labs Sa
Ingredient:fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090859
Medical Subject Heading (MeSH) Categories for 090859
Suppliers and Packaging for NDA: 090859
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859 ANDA Dr. Reddy's Laboratories Limited 55111-349 N 55111-349-30
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859 ANDA Dr. Reddy's Laboratories Limited 55111-349 N 55111-349-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Mar 1, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Mar 1, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Fish and Richardson
Dow
Chinese Patent Office
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Cerilliant

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