Drug Master Files for: Leo Pharm
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Leo Pharm Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10477 | I | II | 9/3/1993 | LEO PHARMACEUTICAL PRODUCTS LTD | WEXPORT LTD. FACILITIES IN LITTLE ISLAND, CORK, IRELAND FOR THE MANUFACTURE OF HEPARIN SODIUM |
10514 | A | II | 10/8/1993 | LEO PHARMA AS | CALCIPOTRIENE HYDRATE DRUG SUBSTANCE |
10515 | A | II | 10/8/1993 | LEO PHARMA AS | CALCIPOTRIENE CREAM DRUG PRODUCT |
10589 | I | II | 11/22/1993 | LEO PHARMACEUTICAL PRODUCTS LTD | HEPARIN SODIUM DRUG SUBSTANCE |
10596 | I | II | 12/7/1993 | LEO PHARMACEUTICAL PRODUCTS LTD | TINZAPARIN SODIUM DRUG SUBSTANCE |
10597 | I | II | 12/7/1993 | LEO PHARMACEUTICAL PRODUCTS LTD | INNOHEP INJECTION 20,000 ANTI-XA IR/ML |
10839 | I | II | 3/30/1994 | LEO PHARMA AS | CALCIPOTRIENE SCALP SOLUTION |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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