Drug Master Files for: METHYLNALTREXONE BROMIDE

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METHYLNALTREXONE BROMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22553	A	II	2/16/2009	SPECGX LLC	METHYLNALTREXONE BROMIDE, CODE 1251
26528	A	II	9/14/2012	NORAMCO GMBH	METHYLNALTREXONE BROMIDE
30173	A	II	12/30/2016	CHONGQING LAND TOWER PHARMACEUTICAL CO LTD	METHYLNALTREXONE BROMIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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