Drug Master Files for: sitagliptin phosphate

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sitagliptin phosphate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23864	A	II	6/3/2010	MSN PHARMACHEM PRIVATE LTD	SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (ROUTE CODE SG)
24067	A	II	8/16/2010	MYLAN LABORATORIES LTD	SITAGLIPTIN PHOSPHATE
24148	A	II	9/9/2010	TEVA PHARMACEUTICAL INDUSTRIES LTD	SITAGLIPTIN PHOSPHATE
24199	A	II	10/9/2010	SUN PHARMACEUTICAL INDUSTRIES LTD	SITAGLIPTIN PHOSPHATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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