Drug Master Files for: Fresenius
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Fresenius Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11240 | A | V | 12/7/1994 | FRESENIUS KABI USA LLC | MANUFACTURING FACILITY IN GRAND ISLAND, NY. |
11342 | A | V | 2/13/1995 | FRESENIUS KABI USA LLC | MANUFACTURING FACILITY IN MELROSE PARK, IL |
13134 | A | V | 8/17/1998 | FRESENIUS KABI NORGE AS | STERILE MANUFACTURING OPERATIONS IN HALDON, NORWAY |
14395 | I | II | 9/8/1999 | FRESENIUS KABI ONCOLOGY LTD | METAXALONE |
15253 | A | II | 2/16/2001 | FRESENIUS KABI AUSTRIA GMBH | LACTULOSE SOLUTION USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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