Drug Master Files for: daunorubicin citrate
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daunorubicin citrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11879 | A | II | 2/29/1996 | MICROBIOPHARM JAPAN CO LTD | DAUNORUBICIN HYDROCHLORIDE (CRUDE) |
| 13503 | I | II | 9/1/1998 | RHONE POULENC RORER PHARMACEUTICALS INC | DAUNORUBICIN HYDROCHLORIDE |
| 13727 | A | II | 9/1/1998 | MEIJI SEIKA PHARMA CO LTD | DAUNORUBICIN HYDROCHLORIDE (DRUG SUBSTANCE) |
| 13775 | A | II | 9/1/1998 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | DAUNORUBICIN HYDROCHLORIDE USP |
| 13786 | A | II | 9/1/1998 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DAUNORUBICIN HYDROCHLORIDE |
| 17218 | I | II | 3/4/2004 | CHEMWERTH INC | DAUNORUBICIN HYDROCHLORIDE (TECHNICAL GRADE) |
| 21163 | A | II | 12/17/2007 | GALEN LTD | DAUNOXOME FOR INJECTION (DAUNORUBICIN CITRATE LIPOSOME) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
