Drug Master Files for: DILTIAZEM HYDROCHLORIDE

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DILTIAZEM HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10381	I	II	7/9/1993	MITSUBISHI TANABE PHARMA CORP	DILTIAZEM HYDROCHLORIDE (PROCESS C)
10466	I	II	6/2/1993	SUMITRA PHARMACEUTICALS AND CHEMICALS LTD	DILTIAZEM HYDROCHLORIDE
11077	I	II	9/9/1994	TANABE SEIYAKU CO LTD	DILTIAZEM MALATE
11161	I	II	10/24/1994	MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC	DILTIAZEM ER TABLETS
11170	I	II	10/28/1994	MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC	ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
11504	I	II	5/11/1995	DR REDDYS LABORATORIES LTD	DILTIAZEM HYDROCHLORIDE
12071	I	II	8/2/1996	ORION CORP FERMION	DILTIAZEM HCL PROCESS II
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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