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Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Express Scripts
Chinese Patent Office
Mallinckrodt
Farmers Insurance
Deloitte
Daiichi Sankyo
Novartis
Teva

Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202252

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NDA 202252 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, and Rhodes Pharms, and is included in eight 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 202252

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

Pharmacology for NDA: 202252

Medical Subject Heading (MeSH) Categories for 202252

Suppliers and Packaging for NDA: 202252

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202252 ANDA Apotex Corp. 60505-3120 60505-3120-1 100 CAPSULE in 1 BOTTLE (60505-3120-1)
FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202252 ANDA Apotex Corp. 60505-3120 60505-3120-3 30 CAPSULE in 1 BOTTLE (60505-3120-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength43MG
Approval Date:Jul 26, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength130MG
Approval Date:Jul 26, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
McKinsey
Novartis
Argus Health
Dow
AstraZeneca
US Army
Cerilliant
Julphar
Cantor Fitzgerald

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