Drug Master Files for: STAVUDINE

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STAVUDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17646	A	II	8/31/2004	CIPLA LTD	STAVUDINE USP
17968	A	II	12/30/2004	AUROBINDO PHARMA LTD	STAVUDINE USP
17976	I	II	1/6/2004	MYLAN LABORATORIES LTD	STAVUDINE USP
17997	A	II	1/17/2005	HETERO LABS LTD	STAVUDINE
19837	A	II	9/29/2006	AUROBINDO PHARMA LTD	STAVUDINE USP (NON-STERILE DRUG SUBSTANCE)
19863	A	II	10/3/2006	ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE	STAVUDINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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