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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
Baxter
US Department of Justice
Merck
Citi
Boehringer Ingelheim
Johnson and Johnson
Cantor Fitzgerald
Farmers Insurance

Generated: October 20, 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 fifty suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. Fifty-one 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 leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
Baxter
Fuji
Teva
Express Scripts
Fish and Richardson
Dow
Boehringer Ingelheim
Cerilliant

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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