Drug Master Files for: EZETIMIBE
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EZETIMIBE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19717 | A | II | 8/30/2006 | GLENMARK PHARMACEUTICALS LTD | EZETIMIBE (PROCESS I) |
| 20039 | A | II | 12/13/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | EZETIMIBE |
| 21554 | A | II | 4/17/2008 | MSN LABORATORIES PRIVATE LTD | EZETIMIBE USP [ROUTE CODE - EB] |
| 22573 | I | II | 2/25/2009 | NEULAND LABORATORIES LTD | EZETIMIBE (FORM-X) |
| 23541 | A | II | 4/7/2010 | LUPIN LTD | EZETIMIBE |
| 24511 | A | II | 12/30/2010 | CHANGZHOU PHARMACEUTICAL FACTORY | EZETIMIBE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
