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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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