Drug Master Files for: MANNITOL

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MANNITOL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12879	A	II	2/26/1998	ROQUETTE FRERES	MANNITOL USP GRADE (PEARLITOL PF)
14891	A	IV	5/16/2000	ROQUETTE FRERES	MANNITOL, SPRAY DRIED
16362	I	IV	1/16/2003	SPI PHARMA INC	MANNOGEM(TM) EZ SPRAY DRIED MANNITOL USP
171	I	II	8/16/1955	NEW DRUG INSTITUTE	RAUWOLFIA SERPERTINA WHOLE ROOT,MANNITOL HEXANITRATE ,
18143	A	IV	3/8/2005	ROQUETTE FRERES	MANNITOL USP POWDER PEARLITOL ?
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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