Drug Master Files for: ospemifene
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ospemifene Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25541 | A | II | 11/30/2011 | FERMION OY | OSPEMIFENE |
| 29720 | A | II | 9/24/2015 | OLON SPA | OSPEMIFENE |
| 30474 | A | II | 6/13/2016 | TIANJIN WEIJIE PHARMACEUTICAL CO LTD | OSPEMIFENE |
| 30574 | A | II | 6/30/2016 | GLENMARK PHARMACEUTICALS LTD | OSPEMIFENE |
| 30858 | A | II | 10/17/2016 | HONOUR LAB LTD | OSPEMIFENE |
| 31163 | A | II | 12/17/2018 | CAMBREX KARLSKOGA AB | OSPEMIFENE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
