Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 5, 2019

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Drug Master Files for: cisatracurium

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cisatracurium Drug Master Files

DMF No. Status Type Submission Date Holder Subject
22962 A II 7/21/2009 GLAND PHARMA LTD CISATRACURIUM BESYLATE
23130 A II 9/28/2009 TEVA PHARMACEUTICAL INDUSTRIES LTD CISATRACURIUM BESYLATE
23554 A II 2/21/2010 WAVELENGTH ENTERPRISES LTD CISATRACURIUM BESYLATE
24033 I II 7/14/2010 ALP PHARM BEIJING CO LTD CISATRACURIUM BESYLATE
24902 A II 8/27/2012 CF PHARMA LTD CISATRACURIUM BESYLATE VERSION FA1
24969 A II 8/27/2012 CF PHARMA LTD CISATRACURIUM BESYLATE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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