Drug Master Files for: ofloxacin
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ofloxacin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10102 | A | II | 2/26/1993 | DAIICHI SANKYO CO LTD | LEVOFLOXACIN DRUG SUBSTANCE |
| 10353 | A | II | 7/13/1993 | BAYER AG | CIPROFLOXACIN HYDRATED DRUG SUBSTANCE |
| 10922 | I | II | 5/25/1994 | NORAMCO INC | OFLOXACIN |
| 11602 | I | II | 2/5/1996 | UNION QUIMICO FARMACEUTICA SA | CIPROFLOXACIN HYDROCHLORIDE |
| 11966 | A | II | 2/21/1996 | QUIMICA SINTETICA SA | CIPROFLOXACIN HYDROCHLORIDE (NEW SYNTHETIC PATHWAY) |
| 13072 | I | II | 7/13/1998 | SUN PHARMACEUTICAL INDUSTRIES LTD | CIPROFLOXACIN HYDROCHLORIDE USP |
| 13250 | A | II | 9/29/1998 | NEULAND LABORATORIES LTD | CIPROFLOXACIN HYDROCHLORIDE, 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
