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Last Updated: November 4, 2024

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Drug Master Files for: ALCOHOL


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ALCOHOL Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10366 A III 7/21/1993 KURARAY AMERICA INC ETHYLENE/VINYL ALCOHOL COPOLYMERS
10498 A II 9/28/1993 GRAIN PROCESSING CORP ETHYL ALCOHOL PRODUCTS
10960 I IV 6/24/1994 HULS AKTIENGESELLSCHAFT DEHYDRATED ALCOHOL (ETHANOL) USP
12516 I III 5/20/1997 BASF CORP LUTONAL A 50, 50% IN ETHYL ALCOHOL
14460 I IV 9/21/1999 FONA INTERNATIONAL INC 852.330 RED PUNCH FLAVOR NAT AND ART(ALCOHOL FREE)
14462 I IV 9/21/1999 FONA INTERNATIONAL INC 825.527 CHERRY FLAVOR NAT AND ART(ALCOHOL FREE) ETOH
14858 I IV 4/25/2000 FONA INTERNATIONAL INC #906.440 BLUE RASPBERRY FLAVOR, ARTIFICIAL (ALCOHOL FREE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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