Drug Master Files for: NIZATIDINE

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NIZATIDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13192	A	II	9/21/1998	SOLARA A PHARMA SCIENCES LTD	NIZATIDINE
14036	A	II	3/16/1999	DR REDDYS LABORATORIES LTD	NIZATIDINE USP
14101	I	II	4/30/1999	EURO CHEMI INC	NIZATIDINE
14710	I	II	2/10/2000	WOCKHARDT LTD	NIZATIDINE USP
18545	I	II	7/20/2005	OLON SPA	NIZATIDINE
6029	I	II	9/23/1985	ELI LILLY INDUSTRIES INC	BULK PRODUCTION OF NIZATIDINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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