Drug Master Files for: BLEOMYCIN SULFATE
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BLEOMYCIN SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12814 | I | II | 1/6/1998 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE |
| 12962 | A | II | 4/24/1998 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | BLEOMYCIN SULFATE USP |
| 13254 | I | II | 10/2/1998 | MAYNE PHARMA USA INC | BLEOMYCIN SULFATE |
| 13784 | A | II | 9/1/1998 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BLEOMYCIN SULFATE |
| 26312 | A | II | 9/21/2012 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | BLEOMYCIN SULFATE USP (PROCESS II) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
