Drug Master Files for: STERILE WATER FOR INJECTION

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STERILE WATER FOR INJECTION Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10003	A	II	11/25/1992	ACS DOBFAR SPA	SODIUM CARBONATE STERILE
10009	I	V	7/30/1990	ASTELLAS PHARMA INC	STERILE PROCESSING FACILITIES FOR CEFTIZOXIME SODIUM, STERILE (BULK) LOCATED IN TAKAOKA, JAPAN
10076	I	V	12/18/1986	ACS DOBFAR SPA	STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS AT THE VIALE ADDETTA PLANT IN MILANO, ITALY
10077	A	V	8/27/1991	ACS DOBFAR SPA	STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS
10120	I	II	12/4/1989	BIOCHIMICA OPOS 2 SPA	ACT, BULK, NON-STERILE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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