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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Deloitte
Colorcon
Express Scripts
Argus Health
Cantor Fitzgerald
Chubb
Dow
Johnson and Johnson

Generated: February 21, 2018

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
18111AII2/10/2005RL 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Argus Health
Healthtrust
Colorcon
Fish and Richardson
Covington
Queensland Health
Express Scripts
UBS
Moodys
Baxter

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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