Drug Master Files for: rotigotine
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rotigotine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25863 | I | II | 3/7/2012 | OLON SPA | ROTIGOTINE |
| 26236 | A | II | 7/12/2012 | WAVELENGTH ENTERPRISES LTD | ROTIGOTINE |
| 26481 | A | II | 9/26/2012 | INTERQUIM SA | ROTIGOTINE |
| 27370 | A | II | 8/30/2013 | MYLAN LABORATORIES LTD | ROTIGOTINE |
| 27554 | A | II | 9/13/2013 | OLON USA INC | ROTIGOTINE POLYMORPH II |
| 29468 | A | II | 6/30/2015 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ROTIGOTINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
