Drug Master Files for: norfloxacin
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norfloxacin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11139 | I | II | 10/13/1994 | WYCKOFF CHEMICAL CO INC | NORFLOXACIN |
| 11811 | A | II | 1/15/1996 | CIPLA LTD | NORFLOXACIN USP |
| 19021 | I | II | 12/5/2005 | SMRUTHI ORGANICS LTD | NORFLOXACIN USP |
| 5195 | I | II | 12/21/1983 | KYORIN PHARMACEUTICAL CO LTD | NORFLOXACIN |
| 8415 | I | II | 2/6/1990 | CIPLA LTD | NORFLOXACIN |
| 8490 | I | II | 3/20/1990 | QUIMICA SINTETICA SA | NORFLOXACIN USP XXII |
| 9360 | I | II | 10/2/1991 | CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD | NORFLOXACIN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
