Drug Master Files for: GLIPIZIDE
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GLIPIZIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10046 | A | II | 1/19/1993 | URQUIMA SA | GLIPIZIDE |
| 10622 | I | II | 12/17/1993 | PHARMACO LIFE SCIENCE RESEARCH | HPLC ANALYSIS OF GLIPIZIDE IN HUMAN PLASMA IN RICHMOND, VIRGINIA |
| 11024 | I | II | 8/5/1994 | CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD | GLIPIZIDE |
| 12374 | A | II | 2/24/1997 | USV PRIVATE LTD | GLIPIZIDE USP |
| 13101 | A | II | 7/30/1998 | AMSA SPA | GLIPIZIDE |
| 15174 | A | II | 12/4/2000 | FERMION OY | GLIPIZIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
