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Last Updated: March 28, 2024

Drug Master Files for: nicotine


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nicotine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10527 I II 8/31/1993 FINE CHEMICALS CORP NICOTINE POLACRILEX
10634 I II 12/15/1993 PHARMACIA AND UPJOHN MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN.
10739 A II 2/1/1994 NICOBRAND LTD NICOTINE POLACRILEX RESIN
12584 I II 7/11/1997 NICOBRAND LTD NICOTINE BITARTRATE DIHYDRATE
13015 I II 6/10/1998 MCNEIL CONSUMER HEALTHCARE NICOTINE PURIFICATION PROCESS
14193 I II 5/7/1999 SALSBURY CHEMICALS INC NICOTINE POLACRILEX RESIN
16166 A II 10/1/2002 CAMBREX CHARLES CITY INC NICOTINE POLACRILEX, 15%, 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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