Drug Master Files for: ferric carboxymaltose
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ferric carboxymaltose Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16056 | A | II | 7/22/2002 | PANION AND BF BIOTECH INC | FERRIC CITRATE |
17602 | I | II | 8/13/2004 | CILAG AG | SODIUM FERRIC GLUCONATE |
17645 | I | II | 8/30/2004 | OPOCRIN SPA | SODIUM FERRIC GLUCONATE |
17746 | A | II | 10/7/2004 | BIOFER SPA | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE |
18541 | A | II | 7/29/2005 | NAVINTA LLC | SODIUM FERRIC GLUCONATE COMPLEX |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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