Drug Master Files for: cannabidiol
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cannabidiol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
22103 | A | II | 10/17/2008 | STI PHARMACEUTICALS LTD | SYNTHETIC CANNABIDIOL (CBD) |
28255 | A | II | 4/28/2014 | INSYS MANUFACTURING LLC | CANNABIDIOL |
30638 | A | II | 6/30/2016 | AMRI RENSSELAER INC | CANNABIDIOL DRUG SUBSTANCE |
30658 | A | II | 9/27/2016 | NATIONAL CENTER FOR NATURAL PRODUCTS RESEARCH | CANNABIDIOL |
32522 | A | II | 3/2/2018 | BOTANIX PHARMACEUTICALS LTD | BTX-1503 TOPICAL LIQUID, 5% CANNABIDIOL |
32552 | A | II | 11/12/2018 | INSYS MANUFACTURING LLC | CANNABIDIOL |
32715 | A | II | 4/23/2018 | THC PHARM GMBH | CANNABIDIOL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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