Drug Master Files for: enalapril maleate

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enalapril maleate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10200	I	III	4/19/1993	3M PHARMACEUTICALS	METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN URINe
11170	I	II	10/28/1994	MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC	ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
11525	A	II	5/19/1995	FARMHISPANIA SA	ENALAPRIL MALEATE
11622	I	V	7/20/1995	PHARMACO LIFE SCIENCE RESEARCH	METHOD MS23.1, GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN URINE
11623	I	V	7/20/1995	PHARMACO LIFE SCIENCE RESEARCH	METHOD MS23 REVISION 1 GC/MS ANALYSIS OF ENALAPRIL AND ENALAPRILAT IN HUMAN PLASMA
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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