Drug Master Files for: ZIDOVUDINE

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ZIDOVUDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10866	I	II	4/7/1994	ESTEVE QUIMICA SA	AZT (ZIDOVUDINE)
13181	I	II	9/10/1998	ST PHARM CO LTD	ZIDOVUDINE DRUG SUBSTANCE
16677	A	II	6/30/2003	CIPLA LTD	ZIDOVUDINE USP
17638	A	II	8/18/2004	AUROBINDO PHARMA LTD	ZIDOVUDINE USP
17751	A	II	10/8/2004	MYLAN LABORATORIES LTD	ZIDOVUDINE USP ( PROCESS-I)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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