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Serving leading biopharmaceutical companies globally:

Deloitte
Dow
Federal Trade Commission
Chinese Patent Office
Citi
US Department of Justice
Johnson and Johnson
Colorcon
McKesson
AstraZeneca

Generated: January 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

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DMF No. Status Type Submission Date Holder Subject
453AII7/13/1965FIS FABBRICA ITALIANA SINTETICI SPANITROFURANTOIN & NITROFURANTOIN MACROCRYSTALS
454III12/7/1961PRODOTTI CHIMICI DOTTORI RENITROFURANTOIN
1543III7/7/1970ASSIA CHEMICAL LABORATORIES LTDMANUFACTURE OF NITROFURANTOIN
1733III6/8/1971GEMA SANITROFURANTOIN U.S.P
1860III1/26/1972CAMBREX PROFARMACO MILANO SRLNITROFURANTOIN ANHYDROUS
1861III1/26/1972CAMBREX PROFARMACO MILANO SRLNITROFURANTOIN MONOHYDRATE
7979III3/17/1989BOEHRINGER MANNHEIM GMBHNITROFURANTOIN MACROCRYSTALLINE
13266AII10/5/1998FIS FABBRICA ITALIANA SINTETICI SPANITROFURANTOIN MONOHYDRATE
15504AII7/11/2001TEVA PHARMACEUTICAL INDUSTRIES LTDNITROFURANTOIN MACROCRYSTALS USP
16505AII4/22/2003TEVA PHARMACEUTICAL INDUSTRIES LTDNITROFURANTOIN MONOHYDRATE USP
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKesson
Novartis
Johnson and Johnson
US Department of Justice
Farmers Insurance
Dow
Express Scripts
QuintilesIMS
Harvard Business School
UBS

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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