Drug Master Files for: CEFDINIR
✉ Email this page to a colleague
CEFDINIR Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17705 | A | II | 9/24/2004 | LUPIN LTD | CEFDINIR MONOHYDRATE USP |
| 17986 | A | II | 12/1/2004 | OLON SPA | CEFDINIR HYDRATE |
| 18457 | A | II | 6/27/2005 | SANDOZ GMBH | CEFDINIR |
| 19401 | A | II | 5/2/2006 | ORCHID PHARMA LTD | CEFDINIR FORM-B |
| 19607 | A | II | 7/11/2006 | AUROBINDO PHARMA LTD | CEFDINIR USP (CRYSTAL B) |
| 19866 | I | II | 10/13/2006 | RANBAXY LABORATORIES LTD | CEFDINIR |
| 20730 | A | II | 6/28/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CEFDINIR HYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
