Drug Master Files for: cephapirin sodium
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cephapirin sodium Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11757 | A | II | 11/9/1995 | ACS DOBFAR SPA | CEPHAPIRIN ACID |
13483 | A | II | 9/1/1998 | CORDEN PHARMA LATINA SPA | CEPHAPIRIN SODIUM |
13496 | I | II | 9/1/1998 | BARCELONETA INC DIV BRISTOL MYERS | CEPHAPIRIN SODIUM STERILE |
13698 | A | II | 9/1/1998 | ACS DOBFAR SPA | CEPHAPIRIN SODIUM |
18081 | I | II | 2/3/2005 | CORDEN PHARMA LATINA SPA | CEPHAPIRIN BENZATHINE |
24890 | I | II | 4/22/2011 | FRESENIUS KABI ANTI INFECTIVES SRL | CEPHAPIRIN SODIUM STERILE |
26969 | I | II | 3/6/2013 | FRESENIUS KABI ANTI INFECTIVES SRL | CEPHAPIRIN BENZATHINE STERILE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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