Drug Master Files for: CEFAZOLIN SODIUM
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CEFAZOLIN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10129 | I | II | 11/18/1988 | BIOCHIMICA OPOS 2 SPA | CEFAZOLIN FREE ACID |
| 10130 | I | II | 7/31/1986 | BIOCHIMICA OPOS 2 SPA | CEFAZOLIN SODIUM, BULK |
| 10152 | I | V | 8/7/1972 | ASTELLAS PHARMA INC | STERILE PROCESSING FACILITIES FOR CEFAZOLIN SODIUM STERILE, (BULK) AS LOCATED IN FUJI, JAPAN |
| 10156 | I | II | 10/8/1991 | ASTELLAS PHARMA INC | CEFAZOLIN |
| 10303 | A | II | 4/1/1987 | ACS DOBFAR SPA | ACID CEFAZOLIN (INTERMEDIATE GRADE) |
| 10731 | A | II | 11/1/1993 | OLON SPA | CEFAZOLIN ACID |
| 13208 | A | II | 4/30/1998 | ACS DOBFAR SPA | CEFAZOLIN SODIUM LYOPHILIZED (STERILE, BULK) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
