Drug Master Files for: biperiden hydrochloride

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biperiden hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15279	I	III	10/4/2000	PLASDENE GLASS PAK	EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL
1540	I		6/25/1970	KNOLL AG CHEMISCHE FABRIKEN	BIPERIDEN AND BIPERIDEN HYDROCHLORIDE (AKINETON)
2136	I	III	7/30/1973	ARMSTRONG PRODUCTS CO	EFFECTS OF BIPERIDEN ON THE PHARMOKINETICS OF HALOPERIDOL
6616	I	V	10/3/1986	LABORATORY ANALYTICAL BIOLOGY INC	EFFECTS OF BIPERIDEN ON THE PHARMOKINETICS OF HALOPERIDOL
6824	I	V	2/10/1987	SOUTH FLORIDA BIOAVAILABILITY CLINIC INC	EFFECTS OF BIPERIDEN ON THE PHARMACOKINETICS OF HALOPERIDOL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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