Drug Master Files for: TOPOTECAN HYDROCHLORIDE

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TOPOTECAN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19834	I	II	10/4/2006	DR REDDYS LABORATORIES LTD	TOPOTECAN HYDROCHLORIDE
20723	I	II	6/20/2007	SAI PHYTOCEUTICALS PVT LTD	TOPOTECAN HYDROCHLORIDE
20810	A	II	8/22/2007	SCINOPHARM TAIWAN LTD	TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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