Drug Master Files for: GENTAMICIN SULFATE
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GENTAMICIN SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12048 | A | II | 6/30/1996 | FUJIAN FUKANG PHARMACEUTICAL CO LTD | GENTAMICIN SULFATE |
| 12177 | I | I | 10/17/1996 | FUZHOU ANTIBIOTIC GENERAL FACTORY | MANUFACTURING FACILITIES FOR GENTAMICIN SULFATE IN FUZHOU, P.R. CHINA |
| 13437 | I | II | 9/1/1998 | SCHERING PHARMACEUTICAL CORP | GENTAMICIN SULFATE |
| 13620 | I | II | 9/1/1998 | GIST-BROCADES NV PHARMACEUTICALS | GENTAMICIN SULFATE |
| 13625 | I | II | 9/1/1998 | PHARMACHIM ECONOMIC CORP | GENTAMICIN SULFATE |
| 13630 | I | II | 9/1/1998 | SHANGHAI ASIA PIONEER PHARMACEUTICALS CO LTD | GENTAMICIN SULFATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
