Drug Master Files for: Biogen Idec Inc
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Biogen Idec Inc Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
18262 | I | V | 1/30/2004 | BIOGEN IDEC INC | RITUXAN (RITUXIMAB) |
18646 | I | II | 2/26/1997 | BIOGEN IDEC INC | MURINE MONOCLONAL ANTIBODY (2B8) TO CD20 |
18655 | I | II | 8/20/1998 | BIOGEN IDEC INC | IDEC-114 (GALIXIMAB);CHEMERIC (MACAQUE/HUMAN) MONOCLONAL ANTIBODY TO CD80 (B7.1) |
18667 | I | II | 9/20/2000 | BIOGEN IDEC INC | HUMANIZED MONOCLONAL ANTIBODY (IDEC-131) (CHO CELLS, IDEC) TO CD40L (CD 154) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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