Drug Master Files for: ZALEPLON
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ZALEPLON Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11747 | I | II | 11/13/1995 | ZACH SYSTEM SPA | ZALEPLON |
16785 | I | II | 8/20/2003 | AMINO CHEMICALS LTD | ZALEPLON |
17230 | I | II | 3/12/2004 | MEDICHEM SA | ZALEPLON |
17565 | A | II | 7/22/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ZALEPLON |
18022 | A | II | 1/26/2005 | CIPLA LTD | ZALEPLON |
19015 | I | II | 12/13/2005 | GADOR SA | ZALEPLON |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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