Drug Master Files for: Bracco
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Bracco Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10299 | I | II | 6/15/1993 | BRACCO IND CHIMICA SPA | IOMEPROL |
10638 | A | II | 12/13/1993 | BRACCO IMAGING SPA | IOPAMIDOL |
1613 | I | 11/19/1970 | BRACCO IND CHIMICA SPA | IODAMIDE (METIODID) | |
2202 | I | 12/20/1973 | BRACCO IND CHIMICA SPA | IODOXAMIC ACID (BULK) | |
2244 | I | 3/14/1974 | BRACCO IND CHIMICA SPA | IOPRONIC ACID | |
2308 | I | II | 7/30/1974 | BRACCO IND CHIMICA SPA | DIATRIZOIC ACID |
3387 | I | II | 11/14/1978 | BRACCO IND CHIMICA SPA | (B15000), IOPAMIDOL, BULK FORM |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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