Drug Master Files for: selegiline
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selegiline Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10036 | I | II | 12/30/1992 | ARENOL CHEMICAL CORP | SELEGILINE (DEPRENYL) HYDROCHLORIDE |
| 10235 | I | II | 5/5/1993 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SELEGILINE HYDROCHLORIDE |
| 10340 | A | II | 6/28/1993 | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH | SELEGILINE HYDROCHLORIDE |
| 10529 | I | II | 10/14/1993 | IROTEC LABORATORIES | SELEGILINE HYDROCHLORIDE |
| 10821 | I | II | 4/12/1994 | CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTD | FACILITY FOR THE MANUFACTURE OF SELEGILINE HYDROCHLORIDE IN BUDAPEST, HUNGARY |
| 11104 | I | II | 9/28/1994 | SIEGFRIED LTD | SELEGILINE HYDROCHLORIDE |
| 11356 | I | II | 2/20/1995 | RESOLUTION CHEMICALS LTD | SELEGILINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
