Drug Master Files for: fondaparinux sodium
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fondaparinux sodium Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15257 | I | II | 1/19/2001 | GLAXO GROUP LTD DBA GLAXOSMITHKLINE | FONDAPARINUX SODIUM |
| 15259 | I | II | 1/22/2001 | SANOFI CHIMIE | FONDAPARINUX SODIUM |
| 22579 | A | II | 2/26/2009 | DR REDDYS LABORATORIES LTD | FONDAPARINUX SODIUM USP |
| 23863 | A | II | 6/28/2010 | APICORE US LLC | FONDAPARINUX SODIUM USP |
| 25093 | A | II | 6/30/2011 | RELIABLE BIOPHARMACEUTICAL CORP | FONDAPARINUX SODIUM |
| 27336 | A | II | 9/27/2013 | JIANGSU HENGRUI MEDICINE CO LTD | FONDAPARINUX SODIUM USP, NON-STERILE BULK DRUG SUBSTANCE |
| 27475 | A | II | 9/17/2013 | FORMOSA LABORATORIES INC | FONDAPARINUX SODIUM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
