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Last Updated: January 24, 2020

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Drug Master Files for: MENTHOL; METHYL SALICYLATE

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MENTHOL; METHYL SALICYLATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15452 A II 5/11/2001 NAGAOKA AND CO LTD MENTHOL USP
17331 I IV 4/21/2004 TAKASAGO INTERNATIONAL CORP TAK-020184 MICRON(R) ARTIFICIAL MENTHOL FLAVOR
17332 A IV 4/21/2004 TAKASAGO INTERNATIONAL CORP TAK-022173 MICRON(R) NATURAL & ARTIFICIAL MENTHOL FLAVOR
18795 A IV 9/19/2005 UNGERER AND CO N&A MENTHOL FLVP FN-6067
19174 I IV 2/14/2006 FONA INTERNATIONAL INC 875.017 MENTHOL FLAVOR, NATURAL
21854 A IV 7/30/2008 NECTAR LIFESCIENCES LTD MENTHOL USP
22154 A II 11/3/2008 SYMRISE INC MENTHOL, RAC
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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