Drug Master Files for: TEMAZEPAM
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TEMAZEPAM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23160 | A | II | 10/5/2009 | MYLAN LABORATORIES LTD | TEMAZEPAM USP |
| 25364 | A | II | 10/3/2011 | CENTAUR PHARMACEUTICALS PVT LTD | TEMAZEPAM USP |
| 3193 | I | II | 4/5/1978 | WYETH INC | TEMAZEPAM |
| 4376 | A | II | 11/12/1981 | CAMBREX PROFARMACO MILANO SRL | TEMAZEPAM |
| 5223 | A | II | 12/16/1983 | FIS FABBRICA ITALIANA SINTETICI SPA | TEMAZEPAM |
| 5507 | I | II | 7/23/1984 | SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT | TEMAZEPAM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
