Drug Master Files for: rasagiline mesylate
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rasagiline mesylate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
17075 | I | II | 1/7/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | RASAGILINE MESYLATE |
22366 | A | II | 12/30/2008 | MYLAN LABORATORIES LTD | RASAGILINE MESYLATE |
22667 | A | II | 3/25/2009 | AMINO CHEMICALS LTD | RASAGILINE MESYLATE |
22782 | A | II | 5/15/2009 | PAR A TECHNOLOGIES PRIVATE LTD | RASAGILINE MESYLATE (NON STERILE BULK DRUG SUBSTANCE) |
23460 | A | II | 1/18/2010 | DR REDDYS LABORATORIES LTD | RASAGILINE MESYLATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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