Drug Master Files for: TERAZOSIN HYDROCHLORIDE

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TERAZOSIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10035	A	II	1/11/1993	CU CHEMIE UETIKON GMBH	TERAZOSIN HYDROCHLORIDE
10054	I	II	1/21/1993	PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA	TERAZOSIN HYDROCHLORIDE
10319	I	II	6/24/1993	CATALENT PHARMA SOLUTIONS LLC	HYTRIN (TERAZOSIN) SOFT GELATIN CAPSULES
11300	A	II	1/16/1995	TEVA PHARMACEUTICAL INDUSTRIES LTD	TERAZOSIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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