Drug Master Files for: AZELAIC ACID

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AZELAIC ACID Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10857	I	II	4/5/1994	CU CHEMIE UETIKON GMBH	AZELAIC ACID
11615	A	II	8/4/1995	BASF SE	DERMAZ 88 (AZELAIC ACID)
16758	I	II	8/11/2003	COGNIS CORP	DERMAZ(TM) 95 AZELAIC ACID
19481	A	II	5/31/2006	BASF SE	DERMAZ 99 (AZELAIC ACID)
28190	A	II	6/26/2014	BAYER AG	AZELAIC ACID (A)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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