Drug Master Files for: BEPOTASTINE BESILATE
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BEPOTASTINE BESILATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19966 | A | II | 11/15/2006 | UBE INDUSTRIES LTD | BEPOTASTINE BESILATE |
| 27170 | I | II | 7/3/2013 | MEDICHEM MANUFACTURING MALTA LTD | BEPOTASTINE BESILATE |
| 27350 | A | II | 8/14/2013 | BAL PHARMA LTD | BEPOTASTINE BESILATE |
| 27386 | A | II | 8/16/2013 | BAL PHARMA LTD | BEPOTASTINE BESILATE |
| 27465 | A | II | 8/27/2013 | ICROM SPA | BEPOTASTINE BESILATE |
| 28012 | A | II | 3/3/2014 | MSN LABORATORIES PRIVATE LTD | BEPOTASTINE BESILATE [ROUTE CODE - BB] |
| 28901 | A | II | 12/10/2014 | MEDICHEM MANUFACTURING MALTA LTD | BEPOTASTINE BESILATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
