Drug Master Files for: Esi
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Esi Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10026 | I | II | 12/30/1992 | GENESIS INDUSTRIES INC | MANUFACTURING FACILITY IN ELMWOOD, WISCONSIN |
10045 | I | II | 1/13/1993 | NORDIC SYNTHESIS AB | KETOPROFEN |
10214 | I | II | 4/8/1993 | LANCASTER SYNTHESIS DIV MTM RESEARCH CHEMICALS LTD | FACILITIES AND PROCEDURES IN LANCASTER, ENGLAND |
10215 | I | II | 4/8/1993 | LANCASTER SYNTHESIS DIV MTM RESEARCH CHEMICALS LTD | METHYLENE DIPHOSPHONIC ACID |
10486 | I | III | 9/15/1993 | SWIFT ADHESIVES DIV REICHHOLD CHEMICALS INC | SWIFT 2H041 ADHESIVE |
10647 | I | II | 10/28/1993 | ADHESIVES RESEARCH INC | PRESSURE SENSITIVE ADHESIVES USED AS DRUG MATRIXES |
10819 | I | III | 3/10/1994 | MORGAN ADHESIVES CO ROLL PRODUCTS DIV | PHARMACEUTICAL LABEL PRODUCT LINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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