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Last Updated: April 22, 2024

Drug Master Files for: guaifenesin


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guaifenesin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10413 A II 8/13/1993 SYNTHOKEM LABS PRIVATE LTD GUAIFENESIN USP
10988 I II 7/19/1994 SIANG TA PHARMACEUTICAL CO LTD GUAIFENESIN
14234 A II 6/24/1999 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD GUAIFENESIN USP
14372 A II 8/30/1999 GRANULES INDIA LTD GUAIFENESIN USP
15507 I II 6/28/2001 BOEHRINGER INGELHEIM CHEMICALS INC GUAIFENESIN USP
16122 A II 9/4/2002 SEVEN STAR PHARMACEUTICAL CO LTD GUAIFENESIN USP
18029 I II 1/24/2005 NINGBO SMART PHARMACEUTICAL CO LTD GUAIFENESIN 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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