Drug Master Files for: DALTEPARIN SODIUM
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DALTEPARIN SODIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19038 | I | II | 12/15/2005 | RELIABLE BIOPHARMACEUTICAL CORP | DALTEPARIN SODIUM |
| 19658 | I | II | 8/4/2006 | OPOCRIN SPA | DALTEPARIN SODIUM BULK |
| 20541 | A | II | 3/27/2007 | CHANGZHOU QIANHONG BIO PHARMA CO LTD | DALTEPARIN SODIUM |
| 20905 | I | II | 9/25/2007 | DONGYING TIANDONG PHARMACEUTICAL CO LTD | DALTEPARIN SODIUM USP |
| 21950 | I | II | 9/1/2008 | ALP PHARM BEIJING CO LTD | DALTEPARIN SODIUM (DRUG SUBSTANCE, NON-STERILE) |
| 25556 | A | II | 12/20/2011 | GLAND PHARMA LTD | DALTEPARIN SODIUM PH.EUR. |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
