Drug Master Files for: acitretin

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acitretin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16580	I	II	5/12/2003	SUN PHARMACEUTICAL INDUSTRIES LTD	ACITRETIN USP
17001	A	II	12/1/2003	OLON SPA	ACITRETIN
21113	A	II	12/3/2007	ZACH SYSTEM SA	Methoxy-C15-WITTIG Salt (TGN05), Intermediate for Acitretin API
21373	A	II	2/25/2008	CHEMPACIFIC CORP	CH011 (ACITRETIN) DRUG SUBSTANCE
22090	I	II	10/9/2008	BASF SE	ACITRETIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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