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Last Updated: October 5, 2024

Drug Master Files for: VARENICLINE TARTRATE


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VARENICLINE TARTRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23033 I II 7/31/2009 ALP PHARM BEIJING CO LTD VARENICLINE TARTRATE
23441 A II 1/12/2010 MYLAN LABORATORIES LTD VARENICLINE TARTRATE
23708 A II 4/12/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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