Drug Master Files for: POLYMYXIN B SULFATE
✉ Email this page to a colleague
POLYMYXIN B SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13199 | I | II | 4/30/1998 | CULTOR FOOD SCIENCE INC | POLYMYXIN B SULFATE |
| 13536 | A | II | 9/1/1998 | XELLIA PHARMACEUTICALS APS | POLYMYXIN B SULFATE, STERILE |
| 14187 | A | II | 6/10/1999 | XELLIA PHARMACEUTICALS APS | POLYMYXIN B SULFATE |
| 21244 | I | II | 1/9/2008 | WORLD JIANGSU INDUSTRY CO LTD | Polymyxin B Sulfate USP (Non-Sterile Drug Substance) |
| 22030 | A | II | 10/1/2008 | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD | POLYMYXIN B SULFATE |
| 23876 | A | II | 5/31/2010 | BIOTIKA AS | POLYMYXIN B 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
