Drug Master Files for: bupropion hydrochloride

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bupropion hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11054	A	II	8/30/1994	ERREGIERRE SPA	BUPROPION HYDROCHLORIDE USP
11196	I	II	11/14/1994	NORDIC SYNTHESIS AB	BUPROPION HYDROCHLORIDE
11834	A	II	1/29/1996	CHEMI SPA	BUPROPION HYDROCHLORIDE
12089	I	II	8/12/1996	CILAG AG	BUPROPION HYDROCHLORIDE
13851	I	II	11/16/1998	SOLMAG SPA	BUPROPION HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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