Drug Master Files for: cefuroxime sodium
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cefuroxime sodium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10154 | A | II | 3/1/1991 | ACS DOBFAR SPA | CEFUROXIME ACID |
| 13205 | A | II | 4/30/1998 | ACS DOBFAR SPA | CEFUROXIME SODIUM (STERILE BULK) |
| 13675 | I | II | 9/1/1998 | ELI LILLY AND CO | CEFUROXIME SODIUM |
| 14010 | I | II | 3/4/1999 | FARMABIOS SRL | CEFUROXIME |
| 14058 | I | II | 4/7/1999 | SUN PHARMACEUTICAL INDUSTRIES LTD | CEFUROXIME AXETIL USP (CRYSTALLINE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
