Drug Master Files for: etoposide
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etoposide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10191 | I | II | 4/13/1993 | PHARMACEUTICAL FACTORY SHANGHAI INSTITUTE PHARMACEUTICAL INDUSTRY | ETOPOSIDE |
10476 | A | II | 9/17/1993 | NIPPON KAYAKU CO LTD | ETOPOSIDE PHOSPHATE |
10642 | A | II | 12/30/1993 | CIPLA LTD | ETOPOSIDE USP |
13986 | I | II | 2/17/1999 | RP SCHERER CANADA INC | ETOPOSIDE 50MG SOFT-GELATIN CAPSULE |
24332 | I | II | 10/8/2010 | QILU PHARMACEUTICAL CO LTD | ETOPOSIDE (NON-STERILE API) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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