Drug Master Files for: TACROLIMUS

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TACROLIMUS Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11137	I	II	10/13/1994	KLINGE PHARMA GMBH	MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY
16833	A	II	9/12/2003	ASTELLAS PHARMA INC	TACROLIMUS (FK506) DRUG SUBSTANCE
18442	A	II	6/21/2005	BIOCON LTD	TACROLIMUS USP
18908	A	II	10/24/2005	CONCORD BIOTECH LTD	TACROLIMUS USP
18985	A	II	11/28/2005	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	TACROLIMUS
19072	I	II	12/22/2005	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	TACROLIMUS (NON-STERILE A PHARMACEUTICAL INGREDIENT)
19979	A	II	11/20/2006	LEK PHARMACEUTICALS DD	TACROLIMUS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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