Drug Master Files for: BOSENTAN
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BOSENTAN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23255 | A | II | 11/11/2009 | MSN LABORATORIES PRIVATE LTD | BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN'] |
| 23354 | A | II | 12/4/2009 | MYLAN LABORATORIES LTD | BOSENTAN |
| 23455 | A | II | 1/14/2010 | AMINO CHEMICALS LTD | BOSENTAN MONOHYDRATE |
| 23817 | I | II | 12/23/2010 | SUN PHARMACEUTICAL INDUSTRIES LTD | BOSENTAN MONOHYDRATE |
| 24124 | A | II | 9/9/2010 | GLENMARK PHARMACEUTICALS LTD | BOSENTAN |
| 24929 | A | II | 5/9/2011 | ZACH SYSTEM SPA | BOSENTAN MONOHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
