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Serving 500+ biopharmaceutical companies globally:

Dow
Teva
Argus Health
Covington
Novartis
Express Scripts
Moodys
Colorcon
Accenture
US Army

Generated: July 25, 2017

DrugPatentWatch Database Preview

Drug Master Files for: varenicline

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DMF No. Status Type Submission Date Holder Subject
23033III7/31/2009ALP PHARM BEIJING CO LTDVARENICLINE TARTRATE
23441AII1/12/2010MYLAN LABORATORIES LTDVARENICLINE TARTRATE
23708AII4/12/2010TEVA PHARMACEUTICAL INDUSTRIES LTDVARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE
23774AII5/5/2010APOTEX PHARMACHEM INDIA PVT LTDVARENICLINE TARTRATE
23791AII5/6/2010ACTAVIS GROUP PTC EHFVARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]
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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving 500+ biopharmaceutical companies globally:

Cipla
Baxter
Johnson and Johnson
Accenture
Cerilliant
Covington
US Army
Teva
Dow
Merck

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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