Drug Master Files for: ADAPALENE

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ADAPALENE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18756	A	II	9/12/2005	GLENMARK PHARMACEUTICALS LTD	ADAPALENE USP
18826	A	II	9/30/2005	HELSINN ADVANCED SYNTHESIS SA	ADAPALENE
18831	I	II	9/22/2005	ZHEJIANG NEO DANKONG PHARMACEUTICAL CO LTD	ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE)
19169	A	II	2/9/2006	EXCELLA GMBH AND CO KG	ADAPALENE
19621	A	II	7/10/2006	OLON SPA	ADAPALENE DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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