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Details for New Drug Application (NDA): 076635

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NDA 076635 describes FENOFIBRATE, which is a drug marketed by Impax Labs, Valeant Pharms North, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Teva, Sun Pharm Inds Ltd, Mylan Pharms Inc, Hetero Labs Ltd Iii, Apotex Inc, and Dr Reddys Labs Sa, and is included in eighteen NDAs. It is available from thirty suppliers. Additional details are available on the FENOFIBRATE profile page.

The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the fenofibrate profile page.

Summary for NDA: 076635

Tradename:
FENOFIBRATE
Applicant:
Sun Pharm Inds Ltd
Ingredient:
fenofibrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076635

Suppliers and Packaging for NDA: 076635

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRATE
fenofibrate
TABLET;ORAL 076635 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-001 43353-001-19 3060 TABLET, FILM COATED in 1 BOTTLE (43353-001-19)
FENOFIBRATE
fenofibrate
TABLET;ORAL 076635 ANDA Northwind Pharmaceuticals, LLC 51655-901 51655-901-52 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-901-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength54MG
Approval Date:Oct 31, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength107MG
Approval Date:Oct 31, 2005TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Oct 31, 2005TE:ABRLD:No


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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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