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  • Analyze global market entry opportunities
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  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
McKesson
Johnson and Johnson
Teva
Chubb
Novartis
Mallinckrodt
Daiichi Sankyo
Merck

Generated: November 22, 2017

DrugPatentWatch Database Preview

Drug Master Files for: levofloxacin

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DMF No. Status Type Submission Date Holder Subject
10102AII2/26/1993DAIICHI SANKYO CO LTDLEVOFLOXACIN DRUG SUBSTANCE
15672AII10/15/2001QUIMICA SINTETICA SALEVOFLOXACIN
15864AII2/15/2002CIPLA LTDLEVOFLOXACIN HEMIHYDRATE USP
16521AII4/7/2003TEVA PHARMACEUTICAL INDUSTRIES LTDLEVOFLOXACIN
16616III5/29/2003YUHAN CHEMICAL INCLEVOFLOXACIN HEMIHYDRATE
16658AII6/24/2003DR REDDYS LABORATORIES LTDLEVOFLOXACIN HEMIHYDRATE USP
16791AII8/26/2003NEULAND LABORATORIES LTDLEVOFLOXACIN
16908AII10/14/2003SUN PHARMACEUTICAL INDUSTRIES LTDLEVOFLOXACIN USP
16922AII10/21/2003CIPLA LTDLEVOFLOXACIN HEMIHYDRATE USP
17532AII7/13/2004MYLAN LABORATORIES LTDLEVOFLOXACIN USP (HEMIHYDRATE)
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
US Department of Justice
McKesson
Baxter
Colorcon
Federal Trade Commission
Johnson and Johnson
Citi
Teva
Chubb

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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