Drug Master Files for: levofloxacin
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levofloxacin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10102 | A | II | 2/26/1993 | DAIICHI SANKYO CO LTD | LEVOFLOXACIN DRUG SUBSTANCE |
| 15672 | A | II | 10/15/2001 | QUIMICA SINTETICA SA | LEVOFLOXACIN |
| 15864 | A | II | 2/15/2002 | CIPLA LTD | LEVOFLOXACIN HEMIHYDRATE USP |
| 16521 | A | II | 4/7/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | LEVOFLOXACIN |
| 16616 | I | II | 5/29/2003 | YUHAN CHEMICAL INC | LEVOFLOXACIN HEMIHYDRATE |
| 16658 | A | II | 6/24/2003 | DR REDDYS LABORATORIES LTD | LEVOFLOXACIN HEMIHYDRATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
