Drug Master Files for: DOXORUBICIN HYDROCHLORIDE
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DOXORUBICIN HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13136 | I | V | 10/9/1998 | PHARMACIA AND UPJOHN | TOXICOLOGY INFORMATION FOR IODODOXORUBICIN HCL |
| 13209 | A | II | 4/30/1998 | MEIJI SEIKA PHARMA CO LTD | DOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE |
| 13211 | A | II | 4/30/1998 | MICROBIOPHARM JAPAN CO LTD | DOXORUBICIN HYDROCHLORIDE |
| 13726 | A | II | 9/1/1998 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DOXORUBICIN HYDROCHLORIDE |
| 13773 | A | II | 9/1/1998 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | DOXORUBICIN HYDROCHLORIDE USP |
| 13825 | I | II | 11/9/1998 | PHARMACIA AND UPJOHN SPA | IODODOXORUBICIN HCL BULK DRUG SUBSTANCE |
| 13889 | I | II | 12/7/1998 | PHARMACIA AND UPJOHN SPA | IODODOXORUBICIN HCL FOR INJECTION |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
