Drug Master Files for: HALOPERIDOL DECANOATE

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HALOPERIDOL DECANOATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10946	A	II	6/13/1994	JANSSEN PHARMACEUTICA NV	HALOPERIDOL (R001625) DRUG SUBSTANCE
10954	A	II	6/23/1994	JANSSEN PHARMACEUTICA NV	HALOPERIDOL DECANOATE
12530	A	II	5/28/1997	TEVA PHARMACEUTICAL INDUSTRIES LTD	HALOPERIDOL DECANOATE
14226	A	II	6/22/1999	EXCELLA GMBH AND CO KG	HALOPERIDOL
15279	I	III	10/4/2000	PLASDENE GLASS PAK	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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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