Drug Master Files for: abacavir sulfate

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abacavir sulfate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18229	A	II	3/30/2005	MYLAN LABORATORIES LTD	ABACAVIR SULFATE USP
18256	A	II	3/24/2005	AUROBINDO PHARMA LTD	ABACAVIR SULFATE USP
20515	A	II	5/8/2007	OLON USA INC	ABACAVIR SULFATE
22196	A	II	11/17/2008	HETERO LABS LTD	ABACAVIR SULFATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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