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Last Updated: April 25, 2024

Drug Master Files for: Procter And Gamble


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Procter And Gamble Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10067 I II 1/31/1993 PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO DIGOXIN DRUG SUBSTANCE
1373 I II 6/4/1969 PROCTER AND GAMBLE CO MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREENVILLE, SOUTH CAROLINA.
2509 I II 8/15/1975 PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO FACILITY AND ITS OPERATIONS, PUERTO RICO PLANT
25771 I II 6/29/2012 THE PROCTER AND GAMBLE CO ALIGN PRODUCT CONTAINING BIFANTIS (BIFIDOBACTERIUM LONGUM SUBSP. INFANTIS 36524)
2760 I II 10/5/1976 PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO MANUFACTURING PROCESS AND FACILITY AT NORTH NORWICH, NY
4999 I II 5/26/1983 PROCTER AND GAMBLE CO MIAMI VALLEY LABS-EAST MIAMI RIVER RD., CINCINNATI,OHIO
614 I II 3/14/1963 PROCTER AND GAMBLE CO COMPANY'S PROCEDURES FOR TESTING NDA PRIOR TO SUBMITTING FOR APPROVAL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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