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Serving 500+ biopharmaceutical companies globally:

US Army
Deloitte
Healthtrust
Argus Health
Teva
Accenture
Queensland Health
Novartis
Citi
McKesson

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078012

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NDA 078012 describes GEMFIBROZIL, which is a drug marketed by Impax Pharms, Caribe Holdings, Sandoz, Aurobindo Pharma Ltd, Purepac Pharm, Apotex, Invagen Pharms, Sun Pharm Inds Inc, Watson Labs, Mylan, Teva, Cadila Pharms Ltd, Chartwell Molecules, Northstar Hlthcare, and Hikma Pharms, and is included in eighteen NDAs. It is available from forty-nine suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. Fifty suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.

Summary for NDA: 078012

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

Pharmacology for NDA: 078012

Suppliers and Packaging for NDA: 078012

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMFIBROZIL
gemfibrozil
TABLET;ORAL 078012 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-260 24658-260-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-05)
GEMFIBROZIL
gemfibrozil
TABLET;ORAL 078012 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-260 24658-260-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Mar 26, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Julphar
Farmers Insurance
Baxter
Accenture
Moodys
AstraZeneca
Dow
Merck

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