Drug Master Files for: CEFTIZOXIME SODIUM
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CEFTIZOXIME SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10009 | I | V | 7/30/1990 | ASTELLAS PHARMA INC | STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN |
| 10153 | I | II | 5/8/1991 | ASTELLAS PHARMA INC | OXY-COMPOUND AN INTERMEDIATE TO PURIFIED CEFTIZOXIME |
| 12855 | I | II | 2/6/1998 | PHARM ECO LABORATORIES INC | STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN |
| 24454 | A | II | 12/14/2010 | PARABOLIC DRUGS LTD | CEFTIZOXIME SODIUM (STERILE) USP |
| 6250 | I | II | 4/3/1986 | LYPHOMED INC | STERILE CEFTIZOXIME SODIUM USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
