Drug Master Files for: prazepam

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prazepam Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
5776	I	II	3/8/1985	FABBRICA ITALIANA SINTETICI SPA	PRAZEPAM
6516	I	V	7/17/1986	LABORATORY ANALYTICAL BIOLOGY INC	VALIDATION REPORT ON PRAZEPAM AND IT'S MAJOR METABOLITES
7699	I	II	10/3/1988	DIOSYNTH BV	PRAZEPAM
7913	I	II	2/13/1989	RESOLUTION CHEMICALS LTD	PRAZEPAM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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