Drug Master Files for: NITAZOXANIDE

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NITAZOXANIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12124	A	II	9/4/1996	ROMARK BELGIUM BVBA	NITAZOXANIDE
19752	A	II	9/8/2006	SUVEN LIFE SCIENCES LTD	NITAZOXANIDE
23792	A	II	5/6/2010	INDUSTRIALE CHIMICA SRL	NITAZOXANIDE
31541	A	II	12/6/2016	CAMBREX PROFARMACO MILANO SRL	NITAZOXANIDE
32425	A	II	3/2/2018	ROMARK LABORATORIES LC	PLACEBO FOR CTM ALINIA? (NITAZOXANIDE) TABLETS, 500 MG
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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