Drug Master Files for: naltrexone

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naltrexone Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12349	I	II	2/5/1997	TASMANIAN ALKALOIDS PARTY LTD	NALTREXONE BENZOATE
15102	A	II	10/18/2000	ASPEN OSS BV	NALTREXONE HYDROCHLORIDE
15221	I	II	1/3/2001	DIOSYNTH BV	NALTREXONE
15837	A	II	1/31/2002	SPECGX LLC	NALTREXONE METHOBROMIDE
17563	I	II	7/20/2004	NV ORGANON	NALTREXONE
20623	A	II	6/20/2007	SANOFI CHIMIE	NALTREXONE HYDROCHLORIDE
21217	A	II	12/28/2007	SUN PHARMACEUTICAL INDUSTRIES LTD	Naltrexone Hydrochloride USP (Dihydrate 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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