Drug Master Files for: CABAZITAXEL
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CABAZITAXEL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23496 | A | II | 1/29/2010 | SANOFI CHIMIE | CABAZITAXEL ACETONE SOLVATE |
| 25769 | A | II | 2/7/2012 | POLYMED THERAPEUTICS INC | CABAZITAXEL MONOHYDRATE DRUG SUBSTANCE |
| 26462 | I | II | 9/18/2012 | SICHUAN XIELI PHARMACEUTICAL CO LTD | CABAZITAXEL |
| 27339 | A | II | 7/18/2013 | POLYMED THERAPEUTICS INC | CABAZITAXEL ETHYL ACETATE SOLVATE DRUG SUBSTANCE |
| 27441 | A | II | 9/26/2013 | QILU PHARMACEUTICAL CO LTD | CABAZITAXEL |
| 27831 | A | II | 3/3/2014 | MSN LABORATORIES PRIVATE LTD | CABAZITAXEL [ROUTE CODE CZ] |
| 27895 | A | II | 2/18/2014 | DR REDDYS LABORATORIES LTD | CABAZITAXEL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
