Drug Master Files for: BIVALIRUDIN

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BIVALIRUDIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12797	A	II	12/22/1997	POLYPEPTIDE SA	HIRULOG (BIVALIRUDIN)- A PHARMACEUTICAL INGREDIENT
20853	A	II	9/14/2007	AMBIOPHARM INC	BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE
20863	A	II	9/18/2007	TEVA PHARMACEUTICAL INDUSTRIES LTD	BIVALIRUDIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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