Drug Master Files for: ALENDRONATE SODIUM

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ALENDRONATE SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14334	A	II	8/6/1999	CIPLA LTD	ALENDRONATE SODIUM USP
14983	I	II	8/2/2000	ALCHYMARS SPA	ALENDRONATE SODIUM
15409	A	II	4/30/2001	APOTEX PHARMACHEM INC	ALENDRONATE SODIUM TRIHYDRATE USP
15858	I	II	2/12/2002	CHEMI SPA	SODIUM ALENDRONATE
16129	A	II	9/10/2002	SIGNA SA DE CV	ALENDRONATE SODIUM TRIHYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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