Drug Master Files for: CEFOXITIN SODIUM
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CEFOXITIN SODIUM Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11823 | A | II | 1/23/1996 | ACS DOBFAR SPA | CEFOXITIN ACID |
12976 | A | II | 4/30/1998 | ACS DOBFAR SPA | CEFOXITIN SODIUM (STERILE BULK) |
18149 | A | II | 3/8/2005 | ORCHID PHARMA LTD | CEFOXITIN SODIUM USP (STERILE) |
19789 | I | II | 9/19/2006 | ANTIBIOTICOS DO BRASIL LTDA | CEFOXITIN SODIUM STERILE BULK |
20316 | A | II | 2/19/2007 | AUROBINDO PHARMA LTD | CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) |
20635 | I | II | 6/20/2007 | ACS DOBFAR SPA | CEFOXITIN SODIUM USP STERILE 100 GRAMS |
20698 | I | II | 7/16/2007 | FRESENIUS KABI ANTI INFECTIVES SRL | CEFOXITIN SODIUM (STERILE) DRUG SUBSTANCE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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