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Last Updated: March 29, 2024

Drug Master Files for: aminosalicylic


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aminosalicylic Drug Master Files

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)
19618 A II 7/21/2006 SYNTESE AS MESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE
5219 I II 12/23/1983 WAITAKI INTERNATIONAL BIOSCIENCES SUB WAITAKI CANADA LTD 5-AMINOSALICYLIC ACID
5602 I II 11/9/1984 BAYER PHARMA AG 5-AMINOSALICYLIC ACID
5693 A II 1/24/1985 CAMBREX KARLSKOGA AB 5-AMINOSALICYLIC ACID
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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