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Generated: September 24, 2019

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Drug Master Files for: exenatide

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exenatide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17114 A II 1/19/2004 SPECGX LLC EXENATIDE
17227 A II 3/5/2004 BACHEM AMERICAS INC EXENATIDE (BULK)
19646 A II 7/31/2006 POLYPEPTIDE LABORATORIES SWEDEN AB EXENATIDE DRUG SUBSTANCE
27123 A II 7/7/2013 TEVA PHARMACEUTICAL INDUSTRIES LTD EXENATIDE
27714 A II 1/13/2014 POLYPEPTIDE LABORATORIES SWEDEN AB EXENDIN-4 ACETATE (EXENATIDE)
29863 A II 12/31/2015 SUN PHARMACEUTICAL INDUSTRIES LTD EXENATIDE
30924 A II 9/28/2016 POLYPEPTIDE LABORATORIES SWEDEN AB EXENATIDE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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