Drug Master Files for: METOLAZONE

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METOLAZONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11958	A	II	5/2/1996	AMRI RENSSELAER INC	METOLAZONE, USP
16001	I	II	6/10/2002	XIAN LIBANG PHARMACEUTICAL CO LTD	METOLAZONE USP
30310	A	II	3/21/2016	CENTAUR PHARMACEUTICALS PRIVATE LTD	METOLAZONE USP
32868	A	II	6/28/2018	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	METOLAZONE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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