Drug Master Files for: AMINOSALICYLIC ACID

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AMINOSALICYLIC ACID Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14855	I	I	4/28/2000	INFAR SA	5-AMINOSALICYLIC ACID
15982	I	II	5/20/2002	DAIWA CHEMICAL CO LTD	5-ASA CRUDE (5-AMINOSALICYLIC ACID CRUDE)
18742	A	II	9/9/2005	INFAR SA	5-AMINOSALICYLIC ACID I (MESALAMINE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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