Drug Master Files for: ceftriaxone
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ceftriaxone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13656 | I | II | 9/1/1998 | ROCHE PHARMACEUTICALS DIV HOFFMANN LAROCHE INC | CEFTRIAXONE SODIUM |
| 15931 | A | II | 3/26/2002 | LUPIN LTD | CEFTRIAXONE SODIUM USP (STERILE ) |
| 16467 | A | II | 3/12/2003 | SANDOZ GMBH | CEFTRIAXONE SODIUM (STERILE) |
| 16650 | A | II | 6/16/2003 | WOCKHARDT LTD | STERILE CEFTRIAXONE SODIUM USP |
| 17257 | A | II | 3/30/2004 | ORCHID PHARMA LTD | CEFTRIAXONE SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
