Drug Master Files for: oxazepam
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oxazepam Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18115 | I | II | 2/25/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | OXAZEPAM |
| 22060 | A | II | 9/30/2008 | CENTAUR PHARMACEUTICALS PVT LTD | OXAZEPAM USP |
| 4438 | A | II | 2/18/1982 | CAMBREX PROFARMACO MILANO SRL | OXAZEPAM |
| 4939 | I | II | 1/21/1983 | SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT | OXAZEPAM |
| 5208 | A | II | 1/9/1984 | FIS FABBRICA ITALIANA SINTETICI SPA | OXAZEPAM |
| 5268 | I | II | 10/20/1983 | INDUSTRIA CHIMICA PROFARMACO SPA | ACETYL OXIDE (OXAZEPAM INTERMEDIATE) |
| 6445 | I | II | 6/27/1986 | WYETH-AYERST LABORATORIES | OXAZEPAM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
