Drug Master Files for: ondansetron

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ondansetron Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15436	A	II	5/15/2001	DR REDDYS LABORATORIES LTD	ONDANSETRON HYDROCHLORIDE DIHYDRATE USP
15642	A	II	10/1/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	ONDANSETRON HCL DIHYDRATE
15724	A	II	11/15/2001	CIPLA LTD	ONDANSETRON HCL USP
15752	A	II	12/5/2001	CAMBREX CHARLES CITY INC	ONDANSETRON HCL
15783	I	II	12/18/2001	CHEMSOURCE CORP	ONDANSETRON HCL
15990	A	II	5/27/2002	SCINOPHARM TAIWAN LTD	ONDANSETRON HYDROCHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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