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Details for New Drug Application (NDA): 078599

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NDA 078599 describes GEMFIBROZIL, which is a drug marketed by Impax Pharms, Blu Caribe, Sandoz, Aurobindo Pharma Ltd, Purepac Pharm, Apotex, Invagen Pharms, Sun Pharm Inds Inc, Watson Labs, Mylan, Teva, Cadila Pharms Ltd, Dava Pharms Inc, 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. There are twenty drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.

Summary for NDA: 078599

Hikma Pharms
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 078599

Suppliers and Packaging for NDA: 078599

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078599 ANDA West-ward Pharmaceutical Corp 0143-9707 0143-9707-05 500 TABLET, FILM COATED in 1 BOTTLE (0143-9707-05)
TABLET;ORAL 078599 ANDA West-ward Pharmaceutical Corp 0143-9707 0143-9707-30 30 TABLET, FILM COATED in 1 BOTTLE (0143-9707-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Aug 16, 2010TE: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.