Drug Master Files for: GEMCITABINE HYDROCHLORIDE

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GEMCITABINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18810	A	II	9/24/2005	JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD	GEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)
18857	A	II	10/11/2005	DR REDDYS LABORATORIES LTD	GEMCITABINE HYDROCHLORIDE USP
19053	A	II	12/19/2005	SCINOPHARM TAIWAN LTD	GEMCITABINE HYDROCHLORIDE USP
19427	A	II	5/16/2006	SUN PHARMACEUTICAL INDUSTRIES LTD	GEMCITABINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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