Drug Master Files for: linezolid

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linezolid Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14091	A	II	4/22/1999	ALBEMARLE CORP	1LZD-LINEZOLID, STEP 1
19032	A	II	12/15/2005	TEVA PHARMACEUTICAL INDUSTRIES LTD	LINEZOLID
19746	A	II	9/11/2006	GLENMARK PHARMACEUTICALS LTD	LINEZOLID
20269	A	II	2/15/2007	SYMED LABS LTD	LINEZOLID (FORM III)
24506	A	II	12/29/2010	NEULAND LABORATORIES LTD	LINEZOLID USP (FORM-II)
24790	A	II	3/25/2011	ALEMBIC PHARMACEUTICALS LTD	LINEZOLID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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