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Last Updated: March 28, 2024

Drug Master Files for: Mcneil Consumer


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Mcneil Consumer Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10850 I I 3/31/1994 MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ROUND ROCK, TEXAS.
13015 I II 6/10/1998 MCNEIL CONSUMER HEALTHCARE NICOTINE PURIFICATION PROCESS
29236 A II 7/6/2015 JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV NICOTINE OROMUCOSAL SPRAY
32200 A II 2/9/2018 JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV NICOTINE POLACRILEX LOZENGE
3831 I II 6/10/1980 MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC INC NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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