Drug Master Files for: LEUPROLIDE MESYLATE

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LEUPROLIDE MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10416	A	II	8/13/1993	TAKEDA PHARMACEUTICAL CO LTD	LEUPROLIDE ACETATE
11236	A	II	12/8/1994	BACHEM AMERICAS INC	LEUPROLIDE ACETATE
12052	I	II	7/18/1996	SPECGX LLC	LEUPROLIDE ACETATE
13150	A	II	8/21/1998	POLYPEPTIDE LABORATORIES INC	LEUPROLIDE
13822	A	II	11/6/1998	BACHEM AG	LEUPROLIDE ACETATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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