Drug Master Files for: doxepin hydrochloride

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doxepin hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
2410	I	II	2/25/1975	BOEHRINGER MANNHEIM GMBH	DOXEPIN
3230	A	II	5/26/1978	TEVA PHARMACEUTICAL INDUSTRIES LTD	DOXEPIN HCL USP
4494	I	II	3/10/1982	SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP	DOXEPIN HCL
5025	A	II	7/21/1983	OLON SPA	DOXEPINE HYDROCHLORIDE
5076	I	II	5/24/1983	SUMIKA FINE CHEMICALS CO LTD	DOXEPIN USP XX
5404	A	II	4/10/1984	DIPHARMA FRANCIS SRL	DOXEPIN HCl
6856	I	II	3/10/1987	GANES CHEMICALS INC PENNSVILLE DIV	DOXEPIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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