Drug Master Files for: VORTIOXETINE HYDROBROMIDE
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VORTIOXETINE HYDROBROMIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 29849 | A | II | 8/15/2016 | ALP PHARM BEIJING CO LTD | VORTIOXETINE HYDROBROMIDE |
| 30309 | A | II | 3/10/2016 | MSN PHARMACHEM PRIVATE LTD | VORTIOXETINE HYDROBROMIDE [ROUTE CODE VX] |
| 31281 | A | II | 12/30/2016 | ALEMBIC PHARMACEUTICALS LTD | VORTIOXETINE HYDROBROMIDE |
| 31314 | A | II | 3/1/2017 | LEK PHARMACEUTICALS DD | VORTIOXETINE HYDROBROMIDE |
| 31389 | A | II | 3/4/2017 | CIPLA LTD | VORTIOXETINE HYDROBROMIDE |
| 31411 | A | II | 2/28/2017 | MSN PHARMACHEM PRIVATE LTD | VORTIOXETINE HYDROBROMIDE (FORM-H) |
| 31492 | A | II | 5/25/2017 | ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD | VORTIOXETINE HYDROBROMIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
