Drug Master Files for: OLANZAPINE

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OLANZAPINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15052	A	II	9/18/2000	CIPLA LTD	OLANZAPINE
15299	A	II	2/23/2001	DR REDDYS LABORATORIES LTD	OLANZAPINE (FORM 1), USP
18108	I	II	2/7/2005	VENKAT PHARMA LTD	OLANZAPINE
18260	A	II	4/8/2005	SOLARA A PHARMA SCIENCES LTD	OLANZAPINE USP
18867	A	II	10/14/2005	MYLAN LABORATORIES LTD	OLANZAPINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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