Drug Master Files for: dronabinol
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dronabinol Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15082 | A | II | 10/6/2000 | S AND B PHARMA INC DBA NORAC PHARMA | DRONABINOL |
| 17629 | I | II | 8/27/2004 | MALLINCKRODT INC | DRONABINOL IN SESAME OIL |
| 18731 | I | II | 9/7/2005 | RESOLUTION CHEMICALS LTD | DRONABINOL USP |
| 19207 | A | II | 2/28/2006 | INSYS MANUFACTURING LLC | DRONABINOL USP |
| 19335 | A | II | 4/7/2006 | RHODES TECHNOLOGIES | DRONABINOL, 10% IN SESAME OIL |
| 20596 | A | II | 6/12/2007 | AMRI RENSSELAER INC | DRONABINOL IN SESAME OIL DRUG SUBSTANCE |
| 20682 | A | II | 7/16/2007 | NORAMCO GMBH | DRONABINOL DRUG SUBSTANCE IN SESAME OIL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
