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Last Updated: April 26, 2024

Drug Master Files for: palonosetron

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palonosetron Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16063	A	II	7/19/2002	HELSINN ADVANCED SYNTHESIS SA	PALONOSETRON HYDROCHLORIDE USP
18187	A	II	3/17/2005	CATALENT PHARMA SOLUTIONS LLC	PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS
21123	A	II	12/11/2007	NEULAND LABORATORIES LTD	PALONOSETRON HYDROCHLORIDE
21749	A	II	7/1/2008	TEVA PHARMACEUTICAL INDUSTRIES LTD	PALONOSETRON HCL
23209	A	II	10/12/2009	ALP PHARM BEIJING CO LTD	PALONOSETRON HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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