Drug Master Files for: METAXALONE
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METAXALONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14394 | I | II | 9/8/1999 | DABUR INDIA LTD | MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR G OF METAXALONE IN KALYANI DIST NADIA WEST BENGAL INDIA |
| 14395 | I | II | 9/8/1999 | FRESENIUS KABI ONCOLOGY LTD | METAXALONE |
| 15087 | A | II | 10/11/2000 | CORDEN PHARMA BERGAMO SPA | METAXALONE |
| 15100 | A | II | 10/19/2000 | ANGELINI ACRAF SPA | METAXALONE |
| 15365 | I | II | 4/1/2001 | PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTD | METAXALONE |
| 15609 | I | II | 8/30/2001 | JOHNSON MATTHEY INC | METAXALONE |
| 16449 | I | II | 3/4/2003 | FDC LTD | METAXALONE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
