Drug Master Files for: buspirone hydrochloride

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buspirone hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10414	I	II	8/9/1993	ARCHIMICA SPA	BUSPIRONE HYDROCHLORIDE
11148	A	II	10/21/1994	FERMION OY	BUSPIRONE HYDROCHLORIDE
11469	I	II	4/12/1995	MEDICHEM SA	BUSPIRONE HYDROCHLORIDE
12135	I	II	9/16/1996	ALKALOIDA CHEMICAL CO ZRT	BUSPIRONE BASE
12172	I	II	10/16/1996	ALKALOIDA CHEMICAL CO ZRT	BUSPIRONE HYDROCHLORIDE
12350	I	II	2/3/1997	EGIS PHARMACEUTICALS PRIVATE LTD	BUSPIRONE HYDROCHLORIDE USP BULK
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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