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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Accenture
Chinese Patent Office
AstraZeneca
Deloitte
Federal Trade Commission
Moodys
Mallinckrodt
Cipla
Cantor Fitzgerald

Generated: September 20, 2017

DrugPatentWatch Database Preview

Drug Master Files for: amitriptyline

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DMF No. Status Type Submission Date Holder Subject
2413III3/10/1975KV PHARMACEUTICAL COAMITRIPTYLINE HYDROCHLORIDE
2598AII1/28/1976OLON SPAAMITRIPTYLINE HCL
2719AII8/9/1976TEVA PHARMACEUTICAL INDUSTRIES LTDAMITRIPTYLINE HCL USP DRUG SUBSTANCE
2908AII3/18/1977DIPHARMA FRANCIS SRLAMITRIPTYLINE HYDROCHLORIDE
3008III7/17/1977SIEGFRIED LTDAMITRIPTYLINE HCL
3449III2/26/1979INDUSTRIA CHEMICA PRODOTTI FRANCIS SPAAMITRIPTYLINE HCL
7059III7/17/1987EGIS PHARMACEUTICALS PRIVATE LTDAMITRIPTYLINE HYDROCHLORIDE
7802III11/28/1988IROPHARM LTDAMITRIPTYLINE HCL B.P. 88/USP
11027III7/21/1994MERIND LTDAMITRIPTYLINE HYDROCHLORIDE USP
18111AII2/10/2005R L FINE CHEM PVT LTDAMITRIPTYLINE HYDROCHLORIDE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Healthtrust
Covington
Daiichi Sankyo
Fish and Richardson
Chinese Patent Office
Merck
US Army
AstraZeneca
Colorcon
Deloitte

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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