Drug Master Files for: SODIUM OXYBATE

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SODIUM OXYBATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10	I		2/23/1944	HERCULES POWDER CO	SODIUM CARBOXYMETHYLCELLULOSE
1000	I		9/15/1966	GENERAL FOODS CORP	MONSODIUM DIHYDROGEN PHOSPHATE
10003	A	II	11/25/1992	ACS DOBFAR SPA	SODIUM CARBONATE STERILE
10006	A	II	12/15/1992	FERMION OY	CROMOLYN SODIUM
10009	I	V	7/30/1990	ASTELLAS PHARMA INC	STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN
10030	I	II	1/5/1993	ARES SERONO SA	SODIUM CHLORIDE FOR INJECTION
10052	I	II	12/9/1992	DIOSYNTH BV	HEPARIN SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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