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Serving leading biopharmaceutical companies globally:

Moodys
Covington
Cipla
Baxter
Medtronic
Colorcon
QuintilesIMS
Queensland Health
Merck
Chubb

Generated: January 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: zolpidem

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DMF No. Status Type Submission Date Holder Subject
31894AII12/29/2017GLENMARK PHARMACEUTICALS LTDZOLPIDEM TARTRATE USP
6622III10/8/1986LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOZOLPIDEM TARTRATE
9159III6/4/1991SYNTHELABO BPZOLPIDEM TARTRATE
10652III1/10/1994GADOR SAZOLPIDEM HEMITARTRATE
11764AII12/5/1995FINORGA SASZOLPIDEM TARTRATE MODIFIED SYNTHESIS
15131AII11/8/2000UQUIFA MEXICO SA DE CVZOLPIDEM TARTRATE
15486AII6/21/2001FARMAK ASZOLPIDEM TARTRATE
15840III1/31/2002QUIMICA SINTETICA SAZOLPIDEM TARTRATE
15958AII4/29/2002TEVA PHARMACEUTICAL INDUSTRIES LTDZOLPIDEM TARTRATE
16624III6/2/2003ZENTIVA KSZOLPIDEM TARTRATE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Daiichi Sankyo
Colorcon
Fuji
US Army
Mallinckrodt
Citi
Harvard Business School
Novartis
UBS
US Department of Justice

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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