Drug Master Files for: Leo Pharm

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Leo Pharm Drug Master Files

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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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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