Drug Master Files for: paliperidone palmitate

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paliperidone palmitate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18915	A	II	11/29/2005	JANSSEN PHARMACEUTICA NV	PALIPERIDONE (R076477) DRUG SUBSTANCE
20902	A	II	10/24/2007	JANSSEN PHARMACEUTICA NV	PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCE
23129	A	II	10/7/2009	JUBILANT GENERICS LTD	PALIPERIDONE
23338	A	II	2/20/2010	UNIMARK REMEDIES LTD	PALIPERIDONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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