Drug Master Files for: NICOTINE

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NICOTINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10527	I	II	8/31/1993	FINE CHEMICALS CORP	NICOTINE POLACRILEX
10634	I	II	12/15/1993	PHARMACIA AND UPJOHN	MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN.
10739	A	II	2/1/1994	NICOBRAND LTD	NICOTINE POLACRILEX RESIN
12584	I	II	7/11/1997	NICOBRAND LTD	NICOTINE BITARTRATE DIHYDRATE
13015	I	II	6/10/1998	MCNEIL CONSUMER HEALTHCARE	NICOTINE PURIFICATION PROCESS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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