Drug Master Files for: SAXAGLIPTIN HYDROCHLORIDE

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SAXAGLIPTIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26924	A	II	4/29/2013	MEDICHEM MANUFACTURING MALTA LTD	SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
26977	A	II	5/3/2013	GLENMARK PHARMACEUTICALS LTD	SAXAGLIPTIN MONOHYDRATE
27083	A	II	7/17/2013	WOCKHARDT BIO AG	SAXAGLIPTIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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