Drug Master Files for: PROPOFOL
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PROPOFOL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10868 | A | II | 4/20/1994 | PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) | PROPOFOL |
| 11204 | A | II | 11/22/1994 | BACHEM SA | PROPOFOL |
| 11406 | I | II | 3/29/1995 | PORTON FINE CHEMICALS LTD | PROPOFOL USP |
| 11474 | I | II | 4/26/1995 | ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV | PROPOFOL |
| 11596 | I | II | 7/25/1995 | ARCHIMICA SPA | BULK CRUDE PROPOFOL |
| 11777 | A | II | 12/8/1995 | SI GROUP | PROPOFOL |
| 15793 | I | II | 1/9/2002 | FIS FABBRICA ITALIANA SINTETICI SPA | PROPOFOL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
