Drug Master Files for: metronidazole

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metronidazole Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16263	A	II	11/18/2002	UNICHEM LABORATORIES LTD	METRONIDAZOLE USP
16380	I	II	1/16/2003	TIANJIN ZHONGAN PHARMACEUTICAL CO LTD	METRONIDAZOLE
19442	I	II	3/10/2006	HEC PHARM CO	METRONIDAZOLE USP, NON-STERILE BULK FORM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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