Drug Master Files for: DEXLANSOPRAZOLE

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DEXLANSOPRAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22607	A	II	3/12/2009	DR REDDYS LABORATORIES LTD	DEXLANSOPRAZOLE (AMORPHOUS)
23380	A	II	12/16/2009	DIPHARMA FRANCIS SRL	DEXLANSOPRAZOLE
23655	A	II	3/22/2010	DR REDDYS LABORATORIES LTD	DEXLANSOPRAZOLE (CRYSTALLINE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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