Drug Master Files for: Zambon Spa
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Zambon Spa Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 5080 | I | II | 7/4/1983 | ZAMBON SPA | MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ALMISANO DI LONIGO (VICENZA). |
| 5485 | I | II | 7/25/1984 | ZAMBON SPA | IBUPROFEN USP XX |
| 5788 | I | II | 3/29/1985 | ZAMBON SPA | DOPAMINE HCL USP XX |
| 6192 | I | II | 1/17/1986 | ZAMBON SPA | THIAMPHENICOL |
| 6349 | I | II | 5/5/1986 | ZAMBON SPA | THIAMPHENICOL GLYCINATE HCL |
| 6872 | I | II | 3/13/1987 | ZAMBON SPA | NAPROXEN USP |
| 7456 | I | II | 4/21/1988 | ZAMBON SPA | NAPROXEN SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
