Drug Master Files for: darifenacin hydrobromide
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darifenacin hydrobromide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22021 | I | II | 9/23/2008 | DR REDDYS LABORATORIES LTD | DARIFENACIN HYDROBROMIDE |
| 22124 | I | II | 10/24/2008 | MEDICHEM MANUFACTURING MALTA LTD | DARIFENACIN HYDROBROMIDE(MED-200380/M) |
| 22184 | A | II | 11/17/2008 | GLENMARK PHARMACEUTICALS LTD | DARIFENACIN HYDROBROMIDE |
| 22206 | A | II | 11/21/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DARIFENACIN HYDROBROMIDE |
| 22225 | A | II | 11/21/2008 | MSN PHARMACHEM PRIVATE LTD | DARIFENACIN HYDROBROMIDE [ROUTE CODE - DF |
| 22371 | I | II | 12/27/2008 | MYLAN LABORATORIES LTD | DARIFENACIN HYDROBROMIDE |
| 23049 | I | II | 8/17/2009 | INTERQUIM SA | DARIFENACIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
