Drug Master Files for: GLYBURIDE
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GLYBURIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10297 | I | II | 6/17/1993 | CHINOIN PHARMACEUTICAL CHEMICAL WORKS | GLIBENCLAMIDE BP88 (GLYBURIDE) |
| 11055 | I | II | 9/1/1994 | SELOC FRANCE | GLYBURIDE |
| 11179 | I | II | 11/4/1994 | HOECHST CELANESE CORP | GLYBURIDE |
| 12136 | I | II | 9/12/1996 | AVENTIS PHARMA DEUTSCHLAND GMBH | GLYBURIDE [MILLED (GROUND)] |
| 12165 | I | II | 10/7/1996 | AVENTIS PHARMA DEUTSCHLAND GMBH | GLYBURIDE (MICRONIZED) BULK DRUG SUBSTANCE |
| 14339 | I | II | 8/10/1999 | USV LTD | GLYBURIDE |
| 15821 | A | II | 1/24/2002 | USV PRIVATE LTD | GLYBURIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
