Drug Master Files for: eszopiclone
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eszopiclone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21412 | I | II | 3/7/2008 | FARMAK AS | ESZOPICLONE |
| 21479 | A | II | 3/25/2008 | MYLAN LABORATORIES LTD | ESZOPICLONE USP |
| 21715 | A | II | 5/12/2008 | TIANJIN TASLY SANTS PHARMACEUTICAL CO LTD | ESZOPICLONE |
| 21853 | A | II | 8/4/2008 | GLENMARK PHARMACEUTICALS LTD | ESZOPICLONE USP |
| 21976 | A | II | 9/13/2008 | DR REDDYS LABORATORIES LTD | ESZOPICLONE |
| 22071 | A | II | 11/27/2008 | ORCHID PHARMA LTD | ESZOPICLONE (NON-STERILE BULK API) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
