Drug Master Files for: docetaxel
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docetaxel Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20021 | A | II | 12/8/2006 | SCINOPHARM TAIWAN LTD | DOCETAXEL USP |
| 20608 | I | II | 6/11/2007 | ACCORD HEALTHCARE INC | ANHYDROUS DOCETAXEL |
| 20722 | I | II | 6/20/2007 | SAI PHYTOCEUTICALS PVT LTD | DOCETAXEL TRIHYDRATE |
| 20942 | A | II | 10/12/2007 | SCINOPHARM TAIWAN LTD | DOCETAXEL TRIHYDRATE USP |
| 20961 | A | II | 10/22/2007 | POLYMED THERAPEUTICS INC | DOCETAXEL ANHYDROUS, NON-STERILE BULK DRUG SUBSTANCE |
| 21040 | A | II | 11/15/2007 | POLYMED THERAPEUTICS INC | DOCETAXEL TRIHYDRATE DRUG SUBSTANCE |
| 21275 | I | II | 1/22/2008 | BENZOCHEM LIFESCIENCES PVT LTD | DOCETAXEL ANHYDROUS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
