Drug Master Files for: etravirine

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etravirine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20440	A	II	4/18/2007	JANSSEN PHARMACEUTICA NV	ETRAVIRINE (R165335) DRUG SUBSTANCE
25550	A	II	12/1/2011	HETERO LABS LTD	ETRAVIRINE
27923	I	II	3/7/2014	APOTEX PHARMACHEM INDIA PVT LTD	ETRAVIRINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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