Drug Master Files for: temozolomide

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temozolomide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19347	A	II	4/10/2006	WAVELENGTH ENTERPRISES LTD	TEMOZOLOMIDE
21669	A	II	5/25/2008	JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD	TEMOZOLOMIDE (BULK, NON-STERILE A PHARMACEUTICAL INGREDIENT)
22775	A	II	5/12/2009	RELIANCE LIFE SCIENCES PVT LTD	TEMOZOLOMIDE USP
23158	A	II	10/6/2009	FORMOSA LABORATORIES INC	TEMOZOLOMIDE
23479	A	II	1/22/2010	SHILPA MEDICARE LTD	TEMOZOLOMIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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