Drug Master Files for: AMINOSALICYLIC ACID
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AMINOSALICYLIC ACID 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 |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
