Drug Master Files for: MITOXANTRONE HYDROCHLORIDE
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MITOXANTRONE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10858 | I | II | 4/11/1994 | CIPLA LTD | MITOXANTRONE HYDROCHLORIDE |
| 12046 | I | II | 7/19/1996 | SYNTHESIA AS | MITOXANTRONE HYDROCHLORIDE USP |
| 12262 | A | II | 12/11/1996 | CHONGQING CARELIFE PHARMACEUTICAL CO LTD | MITOXANTRONE HYDROCHLORIDE USP |
| 12328 | A | II | 1/20/1997 | IDT AUSTRALIA LTD | MITOXANTRONE HYDROCHLORIDE USP |
| 15879 | I | II | 2/27/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MITOXANTRONE HYDROCHLORIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
