Drug Master Files for: MORPHINE SULFATE

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MORPHINE SULFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11529	I	II	7/6/1995	MALLINCKRODT INC	MORPHINE SULFATE INJECTION USP
12808	I	II	12/23/1997	ELAN PHARMA LTD	MORPHINE SULFATE
12818	A	II	1/7/1998	SANOFI CHIMIE	APOMORPHINE HYDROCHLORIDE
13188	A	II	9/11/1998	MACFARLAN SMITH LTD	APOMORPHINE HYDROCHLORIDE
14641	I	II	12/23/1999	ARADIGM CORP	AERX MORPHINE SULFATE PAIN MANAGEMENT SYSTEM
16433	I	II	2/21/2003	ALKERMES INC	AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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