Drug Master Files for: epirubicin hydrochloride
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epirubicin hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16258 | A | II | 10/31/2002 | SYNBIAS PHARMA AG | EPIRUBICIN HYDROCHLORIDE |
| 16324 | A | II | 12/18/2002 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | EPIRUBICIN HYDROCHLORIDE |
| 18307 | A | II | 4/26/2005 | TEVA PHARMACEUTICAL INDUSTRIES LTD | EPIRUBICIN HYDROCHLORIDE LYOPHILIZED |
| 18498 | I | II | 7/6/2005 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | EPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE A PHARMACEUTICAL INGREDIENT |
| 19818 | A | II | 8/18/2006 | SHANDONG NEW TIME PHARMACEUTICAL CO LTD | EPIRUBICIN HYDROCHLORIDE |
| 21303 | A | II | 1/1/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | EPIRUBICIN HYDROCHLORIDE PRECIPITATED |
| 22018 | A | II | 9/19/2008 | MICROBIOPHARM JAPAN CO LTD | EPIRUBICIN HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
