Drug Master Files for: caspofungin acetate
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caspofungin acetate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
22770 | I | II | 5/12/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CASPOFUNGIN |
23222 | I | II | 10/28/2009 | LEK PHARMACEUTICALS DD | CASPOFUNGIN ACETATE |
26978 | A | II | 6/21/2013 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CASPOFUNGIN ACETATE |
27156 | A | II | 6/14/2013 | XELLIA PHARMACEUTICALS APS | CASPOFUNGIN (ACETATE) |
27585 | A | II | 11/27/2013 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | CASPOFUNGIN ACETATE |
28472 | A | II | 11/20/2014 | JIANGSU HENGRUI MEDICINE CO LTD | CASPOFUNGIN ACETATE |
29682 | A | II | 11/12/2015 | SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTD | CASPOFUNGIN ACETATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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