Drug Master Files for: CEFIXIME
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CEFIXIME Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13687 | I | II | 9/1/1998 | LEDERLE LABORATORIES | CEFIXIME |
| 15996 | A | II | 5/20/2002 | LUPIN LTD | CEFIXIME USP |
| 16313 | I | II | 12/17/2002 | SANDOZ PRIVATE LTD | CEFIXIME |
| 17655 | I | II | 9/7/2004 | ORCHID CHEMICALS AND PHARMACEUTICALS LTD | CEFIXIME, USP |
| 19307 | A | II | 3/28/2006 | NECTAR LIFESCIENCES LTD | CEFIXIME USP |
| 19960 | A | II | 11/14/2006 | ORCHID PHARMA LTD | CEFIXIME (PROCESS 2) |
| 23474 | A | II | 1/18/2010 | PARABOLIC DRUGS LTD | CEFIXIME |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
