Drug Master Files for: Merck
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Merck 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. |
| 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 |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
