Drug Master Files for: CINACALCET HYDROCHLORIDE

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CINACALCET HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21264	A	II	1/23/2008	TEVA PHARMACEUTICAL INDUSTRIES LTD	CINACALCET HYDROCHLORIDE
21405	A	II	3/6/2008	MEDICHEM MANUFACTURING MALTA LTD	CINACALCET HYDROCHLORIDE (MED-200140/M )
23910	A	II	6/23/2010	ACTAVIS GROUP PTC EHF	CINACALCET HYDROCHLORIDE (NON-STERILE BULK DRUG SUBSTANCE)
24297	A	II	10/29/2010	IND SWIFT LABORATORIES LTD	CINACALCET HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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