Drug Master Files for: ZOLEDRONIC ACID

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ZOLEDRONIC ACID Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18964	I	II	11/18/2005	PISGAH LABS INC	ZOLEDRONIC ACID MONOHYDRATE (A PHARMACEUTICAL INGREDIENT)
19523	A	II	6/15/2006	NATCO PHARMA LTD	ZOLEDRONIC ACID
19701	A	II	8/22/2006	TEVA PHARMACEUTICAL INDUSTRIES LTD	ZOLEDRONIC ACID
19749	A	II	8/24/2006	CIPLA LTD	ZOLEDRONIC ACID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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