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Last Updated: April 20, 2024

Drug Master Files for: Johnson And Johnson


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Johnson And Johnson Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10187 I I 4/12/1993 JOHNSON AND JOHNSON/MERCK AND COMPANY INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LANCASTER, PENNSYLVANIA.
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
3835 A II 6/10/1980 JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV NICORETTE
4076 I I 12/22/1980 JOHNSON AND JOHNSON GMBH FACILITIES AND PROCEDURES FOR THE
4219 I I 7/15/1981 JOHNSON AND JOHNSON MEDICAL INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDUES IN GURABO, PUERTO RICO.
5307 I II 3/30/1984 IOLAB PHARMACEUTICALS SUB JOHNSON AND JOHNSON CO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN GERMAN, PUERTO RICO (NORTE INDUSTRIAL PARK)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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