Drug Master Files for: pantoprazole sodium

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pantoprazole sodium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15886	A	II	2/28/2002	PMC ISOCHEM	PANTOPRAZOLE SODIUM SESQUIHYDRATE
16657	I	II	6/19/2003	ESTEVE QUIMICA SA	PANTOPRAZOLE SODIUM
16767	I	II	8/14/2003	DOTTIKON EXCLUSIVE SYNTHESIS AG	PANTOPRAZOLE SODIUM SESQUIHYDRATE
17090	A	II	1/8/2004	SUN PHARMACEUTICAL INDUSTRIES LTD	PANTOPRAZOLE SODIUM 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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