Drug Master Files for: IDARUBICIN HYDROCHLORIDE
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IDARUBICIN HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13876 | I | II | 12/4/1998 | SICOR SPA | IDARUBICIN AGLYCONE (BULK CHEMICAL) |
| 13884 | A | II | 12/7/1998 | TEVA PHARMACEUTICAL INDUSTRIES LTD | IDARUBICIN HYDROCHLORIDE |
| 16057 | I | II | 7/18/2002 | PHARMACIA AND UPJOHN SUB PFIZER INC | IDARUBICIN HYDROCHLORIDE |
| 17504 | A | II | 6/26/2004 | SYNBIAS PHARMA AG | IDARUBICIN HYDROCHLORIDE |
| 19185 | I | II | 2/8/2006 | EXOPHARM CO LTD | IDARUBICIN HYDROCHLORIDE, USP NON-STERILE BULK DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
