Drug Master Files for: Iomed
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Iomed Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11609 | I | II | 7/25/1995 | LIFECORE BIOMEDICAL INC | HY-50 HYALURONATE SODIUM STERILE INJECTION |
14514 | I | II | 11/5/1999 | PRONOVA BIOMEDICAL AS | G SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR OSLO NORWAY |
15709 | I | II | 11/8/2001 | BIOMEDISYN CORP | (-)-HUPERZINE A AS IMPORTED BY BIOMEDISYN IN WOODBRIDGE, CT |
20980 | I | II | 10/26/2007 | LIFECORE BIOMEDICAL LLC | ANIMAL COMPONENT FREE SODIUM HYALURONATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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