Drug Master Files for: droperidol

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droperidol Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13897	I	II	12/16/1998	XIAN LIBANG PHARMACEUTICAL CO LTD	DROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE
22975	A	II	7/16/2009	JOINT STOCK CO GRINDEKS	DROPERIDOL USP
4890	I	II	3/31/1983	JANSSEN PHARMACEUTICA NV	DROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES
5773	I	II	3/27/1985	NV ORGANON	DROPERIDOL
7539	I	II	6/9/1988	INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA	DROPERIDOL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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