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Serving leading biopharmaceutical companies globally:

Express Scripts
Healthtrust
Novartis
Cipla
Fuji
AstraZeneca
Federal Trade Commission
Accenture
Queensland Health
Colorcon

Generated: December 12, 2017

DrugPatentWatch Database Preview

Drug Master Files for: dronabinol

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DMF No. Status Type Submission Date Holder Subject
15082AII10/6/2000S AND B PHARMA INC DBA NORAC PHARMADRONABINOL
17629III8/27/2004MALLINCKRODT INCDRONABINOL IN SESAME OIL
18731III9/7/2005RESOLUTION CHEMICALS LTDDRONABINOL USP
19207AII2/28/2006INSYS MANUFACTURING LLCDRONABINOL USP
19335AII4/7/2006RHODES TECHNOLOGIESDRONABINOL, 10% IN SESAME OIL
20596AII6/12/2007AMRI RENSSELAER INC SUB ALBANY MOLECULAR RESEARCH INCDRONABINOL IN SESAME OIL DRUG SUBSTANCE
20682AII7/16/2007NORAMCO GMBHDRONABINOL DRUG SUBSTANCE IN SESAME OIL
20823III8/28/2007BIONORICADRONABINOL USP
23842III5/27/2010CATALENT PHARMA SOLUTIONS LLCDRONABINOL CAPSULES USP 2.5MG, 5.0MG, 10.0MG (CIII) SA
30094AII12/22/2015AMRI RENSSELAER INCDRONABINOL IN ETHANOL DRUG SUBSTANCE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Colorcon
Argus Health
Medtronic
Moodys
Julphar
US Army
Daiichi Sankyo
Farmers Insurance
Express Scripts
Dow

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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