Drug Master Files for: CEFOTAXIME SODIUM
CEFOTAXIME SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12632 | I | II | 8/27/1997 | HAMNMI FINE CHEMICAL CO LTD | CEFOTAXIME ACID |
| 13219 | A | II | 4/30/1998 | LUPIN LTD | STERILE CEFOTAXIME SODIUM USP |
| 14367 | A | II | 8/25/1999 | ACS DOBFAR SPA | CEFOTAXIME SODIUM STERILE |
| 15272 | A | II | 1/30/2001 | ACS DOBFAR SPA | CEFOTAXIME ACID |
| 16839 | I | II | 9/9/2003 | WOCKHARDT LTD | CEFOTAXIME SODIUM (STERILE) |
| 17888 | A | II | 12/9/2004 | ORCHID PHARMA LTD | CEFOTAXIME SODIUM, USP (STERILE BULK) |
| 18154 | I | II | 2/28/2005 | AUROBINDO PHARMA LTD | CEFOTAXIME SODIUM (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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
