Drug Master Files for: NALOXONE HYDROCHLORIDE

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NALOXONE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14034	A	II	3/19/1999	ASPEN OSS BV	NALOXONE HYDROCHLORIDE
1862	A	II	1/25/1972	SPECGX LLC	NALOXONE HCL USP DIHYDRATE
20745	A	II	7/31/2007	MACFARLAN SMITH LTD	Naloxone Hydrochloride
23142	A	II	9/30/2009	SANOFI CHIMIE	NALOXONE HYDROCHLORIDE
23389	A	II	2/22/2010	SUN PHARMACEUTICAL INDUSTRIES LTD	NALOXONE HYDROCHLORIDE DIHYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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