Drug Master Files for: ACARBOSE

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ACARBOSE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18138	A	II	2/24/2005	HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD	ACARBOSE
19069	A	II	12/14/2005	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	ACARBOSE USP
20759	A	II	7/31/2007	CKD BIO CORP	ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE
23279	I	II	11/18/2009	LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTD	ACARBOSE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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