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Generated: July 17, 2019

DrugPatentWatch Database Preview

Drug Master Files for: linaclotide

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linaclotide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24992 A II 5/27/2011 CORDEN PHARMA COLORADO INC LINACLOTIDE
25021 A II 6/1/2011 POLYPEPTIDE LABORATORIES SWEDEN AB LINACLOTIDE DRUG SUBSTANCE
25025 A II 6/7/2011 POLYPEPTIDE LABORATORIES INC LINACLOTIDE DRUG SUBSTANCE
28273 A II 5/5/2014 BACHEM AMERICAS INC LINACLOTIDE (BULK)
29708 A II 9/22/2015 AURO PEPTIDES LTD LINACLOTIDE
30266 A II 11/16/2016 SUN PHARMACEUTICAL INDUSTRIES LTD LINACLOTIDE
DMF No. Status Type Submission Date Holder Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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