Drug Master Files for: ENOXAPARIN SODIUM
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ENOXAPARIN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16748 | I | II | 8/8/2003 | OPOCRIN SPA | ENOXAPARIN SODIUM |
| 18452 | A | II | 5/28/2005 | DONGYING TIANDONG PHARMACEUTICAL CO LTD | ENOXAPARIN SODIUM (NON-STERILE BULK FORM) |
| 21798 | A | II | 7/8/2008 | CELSUS LABORATORIES INC | ENOXAPARIN SODIUM |
| 24316 | A | II | 10/1/2010 | YANTAI DONGCHENG BIOCHEMICALS CO LTD | ENOXAPARIN SODIUM |
| 25242 | A | II | 8/29/2011 | HANGZHOU JIUYUAN GENE ENGINEERING CO LTD | ENOXAPARIN SODIUM |
| 26258 | A | II | 7/30/2012 | HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO LTD | ENOXAPARIN SODIUM |
| 26891 | A | II | 4/17/2013 | SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | ENOXAPARIN SODIUM USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
