Drug Master Files for: mirtazapine
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mirtazapine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10457 | A | II | 8/30/1993 | ASPEN OSS BV | MIRTAZAPINE |
| 15300 | I | II | 2/22/2001 | SUMITOMO CHEMICAL CO LTD | MIRTAZAPINE |
| 15323 | A | II | 3/2/2001 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MIRTAZAPINE |
| 15749 | A | II | 12/5/2001 | MEDICHEM SA | MIRTAZAPINE |
| 16007 | A | II | 6/11/2002 | NEULAND LABORATORIES LTD | MIRTAZAPINE |
| 16014 | I | II | 6/20/2002 | ANGELINI ACRAF SPA | MIRTAZAPINE |
| 16113 | A | II | 8/22/2002 | SUN PHARMACEUTICAL INDUSTRIES LTD | MIRTAZAPINE USP [HEMIHYDRATE] |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
