Drug Master Files for: heparin sodium
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heparin sodium Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10013 | I | II | 12/14/1992 | CHISSO CORP | HEPARIN - CELLUFINE B |
10015 | I | II | 12/14/1992 | CHISSO CORP | HEPARIN - CELLUFINE |
10052 | I | II | 12/9/1992 | DIOSYNTH BV | HEPARIN SODIUM |
1007 | I | II | 11/1/1966 | HOFFMANN LA ROCHE INC | COMPOSITION & GR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307 |
10477 | I | II | 9/3/1993 | LEO PHARMACEUTICAL PRODUCTS LTD | WEXPORT LTD. FACILITIES IN LITTLE ISLAND, CORK, IRELAND FOR THE MANUFACTURE OF HEPARIN SODIUM |
10589 | I | II | 11/22/1993 | LEO PHARMACEUTICAL PRODUCTS LTD | HEPARIN SODIUM DRUG SUBSTANCE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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