Drug Master Files for: gatifloxacin
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gatifloxacin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13902 | I | II | 12/18/1998 | KYORIN PHARMACEUTICAL CO LTD | GATIFLOXACIN |
| 13905 | I | II | 12/21/1998 | HOSPIRA INC | TEQUIN I.V. (GATIFLOXACIN) |
| 15597 | A | II | 8/27/2001 | KYORIN PHARMACEUTICAL CO LTD | GATIFLOXACIN DRUG SUBSTANCE |
| 15599 | I | II | 8/27/2001 | IHARA CHEMICAL INDUSTRY CO LTD | MKS-1 (AS INTERMEDIATE OF GATIFLOXACIN) |
| 16965 | I | II | 11/17/2003 | TEVA GROUP | GATIFLOXACIN |
| 17002 | I | II | 12/3/2003 | CADILA HEALTHCARE LTD | GATIFLOXACIN ANHYDROUS |
| 17012 | A | II | 12/2/2003 | DR REDDYS LABORATORIES LTD | GATIFLOXACIN ANHYDROUS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
