Drug Master Files for: TAMSULOSIN HYDROCHLORIDE

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TAMSULOSIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11761	I	II	12/1/1995	ASTELLAS PHARMA INC	TAMSULOSIN HYDROCHLORIDE
13878	I	II	12/3/1998	ASTELLAS IRELAND CO LTD	TAMSULOSIN HYDROCHLORIDE
17247	I	II	3/19/2004	DR REDDYS LABORATORIES LTD	TAMSULOSIN HYDROCHLORIDE
17318	A	II	4/9/2004	LEK PHARMACEUTICALS DD	TAMSULOSIN HYDROCHLORIDE
17688	A	II	9/17/2004	CADILA HEALTHCARE LTD	TAMSULOSIN HYDROCHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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