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Serving 500+ biopharmaceutical companies globally:

UBS
Cantor Fitzgerald
Daiichi Sankyo
Fish and Richardson
Express Scripts
AstraZeneca
Federal Trade Commission
Queensland Health
Dow
Farmers Insurance

Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075868

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NDA 075868 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Apotex Inc, Rhodes Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Mylan Pharms Inc, and Invagen 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-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 075868

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

Pharmacology for NDA: 075868

Suppliers and Packaging for NDA: 075868

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE (MICRONIZED)
fenofibrate
CAPSULE;ORAL 075868 ANDA Impax Generics 0115-0511 0115-0511-01 100 CAPSULE in 1 BOTTLE (0115-0511-01)
FENOFIBRATE (MICRONIZED)
fenofibrate
CAPSULE;ORAL 075868 ANDA Impax Generics 0115-0522 0115-0522-01 100 CAPSULE in 1 BOTTLE (0115-0522-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength67MG
Approval Date:Oct 27, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength134MG
Approval Date:Oct 27, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Oct 27, 2003TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Argus Health
Mallinckrodt
Johnson and Johnson
McKesson
AstraZeneca
Cerilliant
McKinsey
Covington
Federal Trade Commission

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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