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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200913

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NDA 200913 describes FENOFIBRIC ACID, which is a drug marketed by Alembic Pharms Ltd, Mylan Pharms Inc, Actavis Elizabeth, Lupin Ltd, Impax Labs Inc, and Anchen Pharms, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the FENOFIBRIC ACID profile page.

The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There are ninety-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

Summary for NDA: 200913

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 200913

Suppliers and Packaging for NDA: 200913

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRIC ACID
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL 200913 ANDA Mylan Pharmaceuticals Inc. 0378-2589 0378-2589-77 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2589-77)
FENOFIBRIC ACID
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL 200913 ANDA Mylan Pharmaceuticals Inc. 0378-2590 0378-2590-77 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2590-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Mar 25, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Mar 25, 2013TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
Chubb
Fish and Richardson
Argus Health
McKesson
Cipla
Deloitte
Chinese Patent Office
Baxter
US Department of Justice

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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