Drug Master Files for: ESOMEPRAZOLE SODIUM

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ESOMEPRAZOLE SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17278	I	II	3/31/2004	DR REDDYS LABORATORIES LTD	ESOMEPRAZOLE MAGNESIUM
18559	I	II	8/3/2005	SUN PHARMACEUTICAL INDUSTRIES LTD	ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE)
18821	A	II	9/28/2005	CIPLA LTD	ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP
19192	I	II	2/21/2006	DR REDDYS LABORATORIES LTD	ESOMEPRAZOLE MAGNESIUM (AMORPHOUS FORM)
20222	A	II	1/31/2007	GLENMARK PHARMACEUTICALS LTD	ESOMEPRAZOLE
20392	A	II	4/2/2007	GLENMARK PHARMACEUTICALS LTD	ESOMEPRAZOLE POTASSIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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