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Serving 500+ biopharmaceutical companies globally:

Teva
Colorcon
Covington
Harvard Business School
McKesson
Novartis
Dow
Medtronic
Chubb
Johnson and Johnson

Generated: September 26, 2017

DrugPatentWatch Database Preview

Drug Master Files for: nitrofurantoin

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DMF No. Status Type Submission Date Holder Subject
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
21887AII8/5/2008FIS FABBRICA ITALIANA SINTETICI SPANITROFURANTOIN MONOHYDRATE (CODE 1042)
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Cantor Fitzgerald
Covington
Federal Trade Commission
Novartis
McKesson
Harvard Business School
Cerilliant
Express Scripts
Baxter
AstraZeneca

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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