Drug Master Files for: ESTRADIOL HEMIHYDRATE

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ESTRADIOL HEMIHYDRATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10115	I	II	3/3/1993	PHARMACO LIFE SCIENCE RESEARCH	METHOD VALIDATION REPORT, METHOD 29, GC/MS ANALYSIS OF UNCONJUGATED ESTRONE AND 17B-ESTRADIOL IN HUMAN PLASMA
10536	I	II	10/18/1993	PHARMACIA AND UPJOHN SUB PFIZER INC	ESTRADIOL
10542	I	II	10/25/1993	CYGNUS INC	ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM
10591	I	II	11/24/1993	CYGNUS INC	ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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