Drug Master Files for: Abbott
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Abbott Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10145 | A | II | 3/19/1993 | CANLAC GROUP ABBOTT LABORATORIES LTD | LACTULOSE CONCENTRATE USP |
10186 | I | II | 3/23/1993 | ABBOTT LABORATORIES LTD | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ETHRANE IN QUEENBOUROUGH, KENT, ENGLAND. |
10197 | I | II | 4/17/1993 | ABBOTT LABORATORIES | FACILITIES AND OPERATING PROCEDURES IN LATINA, ITALY (LABORATORI ABBOTT S.P.A.) |
10251 | I | II | 5/14/1993 | ABBOTT LABORATORIES | PROTIRELIN (TRH) |
10272 | I | II | 5/28/1993 | ABBOTT LABORATORIES LTD | SEMI-WORKS AREA IN QUEENBOROUGH, KENT, UNITED KINGDOM |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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