Drug Master Files for: IBANDRONATE SODIUM

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IBANDRONATE SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15429	I	II	5/15/2001	ROCHE DIAGNOSTICS GMBH	IBANDRONATE, EDITION I
20391	A	II	3/31/2007	CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD	SODIUM IBANDRONATE
20393	A	II	3/29/2007	AUROBINDO PHARMA LTD	IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE)
20411	A	II	4/5/2007	NATCO PHARMA LTD	IBANDRONATE SODIUM MONOHYDRATE
20422	A	II	4/9/2007	ORCHID PHARMA LTD	IBANDRONATE SODIUM
20427	A	II	4/5/2007	CHEMI SPA	SODIUM IBANDRONATE MONOHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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