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Harvard Business School
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Generated: November 12, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Merck And Co Inc

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Merck And Co Inc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10393 I II 7/21/1993 MERCK AND CO INC MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LE PUY CEDEX, FRANCE.
10851 I I 3/29/1994 MERCK AND CO INC DIV MERCK SHARP AND DOHME MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOLLATE (MILAN) ITALY.
11161 I II 10/24/1994 MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC DILTIAZEM ER TABLETS
11170 I II 10/28/1994 MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
1140 I V 2/1/1968 MERCK SHARP AND DOHME RESEARCH LABORATORIES DIV MERCK AND CO INC QUALIFICATIONS OF RESEARCH PERSONNEL
11643 I II 9/13/1995 MERCK AND CO INC STERILE DILUENT
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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US Department of Justice

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