Drug Master Files for: AURANOFIN
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AURANOFIN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15803 | A | II | 1/10/2002 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | AURANOFIN |
4212 | I | II | 7/17/1981 | LONZA RIVERSIDE | AURANOFIN |
8292 | I | II | 11/16/1989 | LEK PHARMACEUTICAL AND CHEMICAL CO DD | AURANOFIN |
8389 | I | II | 1/18/1990 | PFANSTIEHL LABORATORIES INC | AURANOFIN |
8648 | I | II | 7/13/1990 | MEDICHEM SA | AURANOFIN |
9658 | I | II | 4/30/1992 | JOHNSON MATTHEY INC | AURANOFIN |
9748 | I | II | 6/29/1992 | SMITHKLINE BEECHAM PHARMACEUTICALS | AURANOFIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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