Drug Master Files for: glimepiride
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glimepiride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15882 | A | II | 2/13/2002 | CHONGQING CARELIFE PHARMACEUTICAL CO LTD | GLIMEPIRIDE USP |
| 16713 | A | II | 7/18/2003 | USV PRIVATE LTD | GLIMEPIRIDE USP |
| 16736 | A | II | 7/28/2003 | MEDICHEM SA | GLIMEPIRIDE |
| 16983 | A | II | 11/26/2003 | DR REDDYS LABORATORIES LTD | GLIMEPIRIDE USP |
| 17048 | I | II | 12/15/2003 | ZACH SYSTEM SPA | GLIMEPIRIDE |
| 17288 | I | II | 4/6/2004 | SUN PHARMACEUTICAL INDUSTRIES LTD | GLIMEPIRIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
